Conference Info:Date: June 26-27, 2013
Location: The Metropolitan Club, New York City
Audience: Institutional investors, high net worth individual investors, family offices, business development executives throughout the US and Europe building and financing high growth medical technology, health care and life science companies.
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6th Annual OneMedForum Presenting Companies
In early June, OneMedForumNY will release the full list of presenting companies.
Until then, we will highlight 7 presenting companies each week. Presenting companies include (click names to view database profiles)…
- Actium BioSystems
- Cyto Wave Technologies
- Del Mar Pharmaceuticals (DMPI)
- Mast Therapeutics (MSTX)
- Response Biomedical Corp. (RBM)
Companies below presented at OneMedForum SF2013, held in January.
Privately-held, company based in the Greater Boston area, in late 2008 to commercialize novel polymer drug delivery technologies to treat various types early stage, soft tissue cancers. AcuityBio’s lead product candidate aimed at preventing the recurrence of non-small cell lung cancer is based on a synthetic polymer technology invented by co-founders Professor Mark Grinstaff, Ph.D. and Jesse Wolinsky.
Advaxis is a biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based upon a novel platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bio-engineered to secrete an antigen/adjuvant fusion (Lm-LLO) protein.
San Diego-based biopharmaceutical company developing proprietary product candidates to treat various diseases and conditions. The Company’s lead product candidate, ANX-188, is an investigational agent that has potential to reduce ischemic tissue injury and end-organ damage by restoring microvascular function, which is compromised in a wide range of serious and life-threatening diseases and conditions. ADVENTRX is initially developing ANX-188 as a treatment for complications arising from sickle cell disease.
A biotechnology company working to develop treatments for cancers and infectious diseases. The company is focused on immunotherapeutic products based on strong platform technologies with multiple product candidates advancing through the clinic. Between Agenus and its partners, 19 programs are in clinical development. Agenus’ QS-21 Stimulon® adjuvant is being studied in clinical trials for 17 vaccine indications. They include four Phase 3 GSK programs: RTS,S for malaria, MAGE-A3 for non-small cell lung cancer and melanoma and Zoster Herpes for shingles. Agenus Phase 2 programs include: Prophage Series G-100 and G-200 for newly diagnosed and recurrent glioma and HerpV for genital herpes.
Pioneering the development of a novel therapeutic protein that has neuron-protective properties – termed MANF – which has the potential to serve as a first-in-class treatment for neurological disorders that stops and/or reverses their debilitating effects. Importantly, MANF is also significantly cardiac-protective, providing Amarantus the ability to employ a two pronged drug development approach – a neurological disorder platform, and a heart disease platform.
Angel Medical Systems
Developed the AngelMed Guardian, the first implantable, patient alerting system designed for early detection and prevention of heart attacks. Time to treatment delays after a heart attack – of more than 3 hours – are primarily caused by patients who postpone calling for help, many times compounded by the fact that nearly 50% of victims have either atypical or no physical symptoms at all. This delay in treatment is the main cause of mortality and morbidity from heart attacks. The Guardian tracks changes in the heart’s electrical signal 24 hours a day, seven days a week and warns patients in advance of or at the first signs of a heart attack, as an emergency alarm is triggered prompting patients to seek immediate medical attention. The Guardian System will significantly reduce the time to treatment as well as the costs of care for heart attack patients, and is primarily intended for use in high risk survivors of a first heart attack.
Asuragen is a molecular diagnostics company with a pioneering position in miRNA using genomics to drive better patient management through best-in-class clinical testing solutions. Today, Asuragen’s products, services and technologies drive countless patient management decisions across oncology, genetic disease, and other molecular testing modalities.
Atossa Genetics, Inc.
Focused on novel cellular and molecular diagnostic risk assessment products for breast cancer. Using patented, FDA-cleared Mammary Aspirate Specimen Cytology Test (MASCT) System, a nurse or physician’s assistant, can painlessly collect a sample of Nipple Aspirate Fluid (NAF) in about 10 minutes, for cytological testing. The MASCT System is FDA cleared for the collection of nipple aspirate fluid for cytological evaluation. The collected fluid can be used in the determination and/or differentiation of normal versus pre-malignant versus malignant cells.
Bacterin International, Inc.
Develops anti-microbial, anti-infective coatings for revolutionary bone graft material and also processes and markets innovative, biologic allografts for transplantation. Objectives of allograft use include pain relief, aid in tissue regeneration, and aid in bone fusion in spinal and sports medicine procedures. Bacterin’s products are divided into three main areas: biologic products, medical devices, and coating technologies. The biologic products focus on human allografts for transplantation, featuring: OsteoSponge, a 100% bone graft designed as an alternative to gels, putties and ill-fitting grafts; OsteoWrap; sports medicine allografts for ACL and PCL repairs and reconstruction as well as meniscal repair); traditional allografts and milled allografts.
Medical device company that designs, patents, and markets medical devices related to well-defined and demonstrated needs in neurosurgery. The founder and CEO, Jan Eckermann M.D., is a practicing neurosurgeon serving as the medical director / principal investigator in the clinic trials, and providing vision and leadership. President Don Kloos is presenting the venture at OneMedForum in San Francisco January 8, 2013. We have designed, prototyped, clinically tested, established insurance reimbursement pathway, and filed patents for the FlowSafe (TM), our first in a series of four products. The FlowSafe automatically controls and monitors the critical fluid drain rates required for lumbar drain in cranial and spinal surgery procedures, and replaces manual human monitoring. Clinical IRB-approved testing was so successful, the participating hospital changed policy to make FlowSafe a standard of care on all lumbar procedures.
BioLife Solutions, Inc.
Develops, manufactures and markets patented hypothermic storage and cryopreservation solutions for cells and tissues. The Company’s proprietary HypoThermosol® and CryoStor® platform of solutions are marketed to academic and commercial organizations involved in regenerative medicine (cell therapy and tissue engineering), bio banking, and drug discovery. BioLife’s products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced, delayed-onset cell damage and death. BioLife’s enabling technology provides academic and clinical researchers significant improvements in post-thaw cell, tissue, and organ viability and function.
Biomay is a contract manufacturing organization (CMO) for GMP-grade recombinant proteins and plasmid DNA. Headquartered in Vienna, Austria, Biomay has manufactured recombinant biomolecules with microbial systems (E. coli, yeasts) for more than 20 years, and develops products for preventative and therapeutic vaccination against allergic diseases.
BOSS Medical is currently developing its first product, the BOSS Harvester – a novel, intuitive system which will enable surgeons to harvest autologous bone graft (autograft) utilizing a minimally invasive approach. Currently, the company is developing a novel surgical device that will enable surgeons to use gold standard autologous bone graft material. Current bone graft solutions are suboptimal in terms of efficacy, safety, and cost. BOSS Medical aims to provide the optimal bone grafting solution in order to improve the lives of our patients worldwide.
(“CardioComm”) has been a consistent provider of ECG management software solutions in the English speaking world for the past 17 years. Its products are marketed as Global EKG Management System (GEMS™ and GlobalCardio™). CardioComm is ISO 13485 certified and its products have been cleared for sale in the United States, Canada and the European Union. Utilizing a patented and proprietary technology and ECG (signal) viewer unlike any other competitor has, and by offering flexible open ended work flow solutions, CardioComm provides the right solution for use with the majority of the world’s cardiac event monitors, including those intended for the home and tele-health market. The Company’s products are sold worldwide to hospitals, call centers and physician’s offices through a combination of its external distribution network and its North American based sales team. CardioComm has achieved its technical goals of improved access and communication through the configurable use of its software for use on a single computer, over a LAN/WAN, or over Internet based networks and ASP services. This technology enables the recording, transfer, viewing, analyzing and storing of electrocardiograms (EKGs) over a global virtual healthcare network by physicians for the diagnosis and management of cardiac patients.
Based in Toronto, Canada, is poised for EU market introduction, CE Mark, in parallel with a broad international clinical testing program of the Company’s proprietary, automated, noninvasive autoRIC™ Device for Remote Ischemic Conditioning (RIC). RIC represents a new $4B market with significant clinical studies published including 5-6 year outcomes studies. Provides 50% reduction of myocardium damage from MI, reduced long term MACE and mortality rates. Placed around the arm, CellAegis’ autoRIC Device allows for the first time, simple, consistent, reliable and cost-effective automation of RIC at the point of care, including acute care applications in the ambulance, emergency room and other hospital settings, or for treatment in the home as directed by a healthcare professional. The autoRIC Device is highly portable and time-efficient, delivering four cycles of simple-to-administer treatment in less than 40 minutes. The device is compatible with current standard-of-care treatments. Discussing opportunities with large device companies with appropriate market channel in pre-hospital, cath lab, cardiac surgery, recovery/DME, and home chronic care.
Speciality pharma company focused on developing, manufacturing, licensing and marketing innovative consumer healthcare products. Clinova currently markets its products in the UK and the emerging markets of Asia, Africa and the MENA region. The leading brand of Clinova is O.R.S a soluble tablet form of the WHO Oral Rehydration Salts formulation and is currently selling in UK with significant international rollout to key markets planned over the course of 2013.
Developing technologies to enable non-invasive quantitative measurements of amyloid aggregates in the eye, to examine and measure deposits in specific areas of the lens as a means of early detection of Alzheimer’s disease. Cognoptix’s SAPPHIRE platform is a combination drug/device product designed to be compact and easy to use for in situ patient examination in a doctor’s office setting.
Developing new oral or injectable small molecule signal
transduction modulator drugs and immune modulator biopharmaceuticals
for cancer, chronic inflammation, pain, infectious, neurodegenerative
or metabolic diseases. Colby Pharmaceuticals is going after
indications for very sick patients with no alternatives, i.e.
metastatic melanomas, gliomas, acute myelogenous leukemias, prostate,
renal or other carcinomas and cancer radio-chemo-therapy
induced-mucositis. The Company’s technology enables highly effective
cancer antigen vaccines using immune activators and vaccine adjuvants
delivered via proprietary ILNI, Intra Lymph Node Immunization. Colby
is building a portfolio of drugs and diagnostics through in-licensing
deals (i.e. Juvaris BioTherapeutics and MannKind Corporation, M&A
(Othera Pharmaceuticals) and proteomics-/genomics-driven in-house
diagnostics and clinical drug product development.
Colibri Technologies, Inc.
Developing minimally invasive imaging technologies with broad clinical relevance. Colibri’s patented 3D imaging catheters will provide physicians with images of the cardiovascular and other organ systems not previously attainable. The 3D imaging catheters will initially be introduced to assist with cardiac procedures that could benefit from better imaging guidance options.Colibri Technologies is developing a suite of image guidance technologies to make modern medical procedures safer, faster, less expensive and more effective.
Product-driven data analytics company that uses cloud-based expert systems to inform healthcare decision-making by aggregating and contextualizing the world’s knowledge on genomics-based medicine, with specific insights from the nation’s top clinical experts. CollabRx’ scalable technology platform blends a cutting-edge medical science and research knowledgebase assembled and curated using artificial intelligence-based search tools and analytics with the insights of practicing clinicians and researchers. CollabRx medical and scientific content is organized in a knowledgebase that expresses the relationship between genetic profiles, other aspects of the medical record (e.g., stage, prior treatments), and therapy considerations including molecular diagnostics, medical tests, clinical trials, drugs, biologics, and other information relevant for treatment planning. Starting with the area of greatest need, advanced cancer, their products and applications inform and facilitate communications between Pathologists and Oncologists and between Oncologists and their patients.
Convergent Medical Systems
Using a face recognition-based algorithm, the largest and proprietary skin-image database, and augmented reality display, we developed the first automated skin diagnosis system, the Lubax (TM). They have obtained patent protection, developed a working prototype, regulatory strategy, and are poised to access a $550M worldwide market for skin screening, monitoring, and diagnosis. Convergent Medical Solutions is seeking the next round of funding to finish the ramp to commercialization.
Provides products and services to the “Omics” marketplace. CustomArray can provide instruments such as the B3™ Synthesizer that uses semiconductor arrays to rapidly synthesize DNA arrays “on chip”. Arrays can be synthesized automatically on the instrument using either the 4x2k™, 12k™, or 90k™ array chips. In situ synthesis on up to 32 arrays (for 4x2k format) or 8 arrays (for other formats) can be performed in under 24 hours. They can also provide pre-made arrays ready for your experiment, and arrays can be read either using standard fluorescence chip readers (one-color or two-color readouts) or can be read using electrochemical detection on their ElectraSense reader. CustomArray also offers extensive services using their platforms to measure gene expression, to measure microRNA expression, to identify aptamer sequences (DNA sequences that bind with high affinity to customer-provided proteins), to identify potent siRNA sequences against select targets in vitro and validate the function of these targets both in vitro and in vivo, to provide large pools of oligos for specific applications such as sequencing, as well as other services
Private medical device company that has developed a breakthrough technological platform for the treatment of heart failure. CorInnova has developed the CardiacSTARTM. It is a minimally invasive, direct cardiac compression device that restores normal cardiac motion to the heart through the application of gentle pressure. The CardiacSTARTM will be the first heart assist device on the market that promotes healthy cardiac motion rather than simply increase blood flow. By promoting correct motion, the device also promotes heart recovery. Unlike prior direct cardiac compression devices, CorInnova’s technology does not invert the curvature of the heart. Moreover, unlike other cardiac assist devices, CorInnova’s device does not touch the blood, eliminating the risk of thrombosis, stroke, and bleeding, and making it non-obligatory.
Critical care focused medical device company using blood purification to treat life threatening diseases commonly seen in the intensive care unit such as sepsis, burn injury, trauma, acute respiratory distress syndrome, pancreatitis and many others. Its flagship product, CytoSorb®, is approved in the European Union as a best-in-class, broad extracorporeal cytokine filter, to be used in clinical situations where cytokines are massively elevated. This “cytokine storm”, if left unabated, can drive uncontrolled severe inflammation, which then can lead to cell death and organ failure – the leading cause of death in the ICU. The ultimate goal of CytoSorb® is to prevent or treat organ failure, something which no other approved therapy addresses today, thereby improving clinical outcome and controlling spiraling critical care costs. The Company is currently generating revenue with CytoSorb® via a direct sales force in Germany, Austria, and Switzerland, and plans to expand via distributors or partners in other countries. The Company is the recent recipient of approximately $5M in contracts from DARPA and the US Army and holds 30 issued US patents.
Focused on the development and commercialization of oncology treatment and supportive care products. DARA is led by a team of strong business leaders comprised of highly experienced and diverse healthcare professionals conducting innovative acquisitions and efficient product development with expertise in clinical development, operations, sales & marketing, strategic planning, and technical operations. DARA’s structure results in success — for patients as well as investors. DARA is as innovative as the therapies they develop and are committed to improving patients’ quality of life.
Targets the biological processes associated with inflammation and degradation of the intervertebral disc through topical and minimally invasive strategies. Discogen devices and therapies will treat a wide variety of back pain disorders that effect an age-related population of over 6 million patients diagnosed with DBP annually. Currently the Discogen is seeking an investment of 3 million (US) to fund the development of the Discogen Ultra-Sound Generator, Hydrogel Delivery System and pilot human clinical studies, in- coordination with Pharma and/or Strategic Partner. Discogen intends to follow regulatory path of 510(k) for both of its patented products thereby accelerating its commercialization as opposed to a PMA regulatory pathway.
Medical device company developing advanced thermal surgical technology for soft tissue cutting and coagulation.The FMwand ferromagnetic surgical technology was originally conceived by pediatric neurosurgeon Kim H. Manwaring, in an effort to create a better alternative to existing energy-based surgical modalities. To date, the company has raised $13 million from the founder, grants, angels, and private venture investors, including BioStar Ventures. With these resources, the capital-efficient company has completed product development and safety certification, built production tooling, secured regulatory clearance, and launched the design award-winning FMwand product line in the U.S.
Developing devices to help physicians place catheters accurately, safely, and quickly. The devices are self-contained, single use, battery-powered, easy to use, and can be used anywhere. Initial indications are for ventricular drain placement for treatment of hydrocephalus – increased intracranial pressure caused by excess cerebrospinal fluid – a deadly condition. They are developing a device that uses diagnostic ultrasound to provide navigation information in a catheterization procedure. The device is completely self-contained, and provides visual guidance information, not images. The device consists of a stylet with an ultrasound transducer at its tip and an ergonomic handle containing batteries, electronics and display. Initial markets are in neurosurgery. Their commercialization strategy is to sign an exclusive license agreement with one of the dominant companies in the image-guided surgery market (Medtronic, J&J Codman, Integra Neuroscience, Aesculap) prior to full-scale commercial manufacturing. The partner will fund tooling and working capital and will purchase, market, and sell private-label products made by the company. Exit is expected to be via acquisition by the strategic partner.
Ellman International, Inc. serves the global aesthetic, multi-specialty surgical, dental and veterinary markets with a full complement of value-based advanced radiofrequency (RF) and laser products for precision surgical and aesthetic procedures. Founded in 1959, Ellman International, Inc., a New York based manufacturer of medical devices for surgical and aesthetic procedures, remains recognized today as a pioneer in the development of specialized radiofrequency technology for precision cutting, coagulating and tissue ablation in physician’s offices, clinics and surgical centers. Ellman provides a wide range of products that are used in the non-surgical and surgical aesthetic markets, general and specialized surgical markets, dental and veterinary medicine in over 65 countries.
The mission of Emmaus Medical is to improve the lives of people with rare disease by the discovery, development and commercialization of innovative and cost-effective medicines. Emmaus Medical’s lead candidate is a treatment for Sickle Cell Disease currently in Phase III clinical trials. The Company markets NutreStore® [L-glutamine powder for oral solution], indicated for the treatment of Short Bowel Syndrome (SBS) in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone approved for this indication. In 2011 Emmaus Medical signed a research agreement with Tokyo-based CellSeed, Inc. The companies are working jointly to develop and commercialize regenerative corneal epithelial sheets in the United States, a technology called “Cell Sheet Engineering.” Clinical trials have been conducted in Europe in patients with limbal stem cell deficiency using this technology.
Pioneer of endoscopically-insertable medical technologies. Founded in 2006, EndoSphere has developed a broad IP portfolio including 29 issued and pending U.S. and international patents. The company’s flagship product, the SatiSphere™ System, is a non-invasive treatment for one of the world’s largest health issues: Metabolic Diseases including Obesity and Type II Diabetes. The SatiSphere device improves the regulation of appetite and satiety by using the body’s natural physiology – providing an incisionless, reversible, and repeatable solution. Clinical studies have shown that the SatiSphere device enables obese patients to achieve significant weight loss without the need for surgery or medication. The device has received CE Mark regulatory approval for commercialization in 31 countries.
A late preclinical stage biotechnology company focused on utilizing its proprietary nanotechnology to efficiently and effectively target atherosclerotic plaques and tumor vasculature for both treatment and imaging applications. The basis of the EnduRx proprietary technology are unique peptides, developed by Dr. Erkki Ruoslahti and his team at the Sanford Burnham Medical Research Institute, that selectively target a micelle carrying a drug to the shoulders of atherosclerotic plaques, and the porous capillaries of neoplasms to deliver a therapeutic payload. The company is using its proprietary technology in a reformulation strategy; reformulating and focusing previously approved generic compounds for use in the cardiovascular and oncology therapy areas. This drug delivery strategy delivers a high local concentration of the drug to increase efficacy, while decreasing the systemic drug concentration to decrease the potential for dangerous side effects.
Enterome is a private personalized medicine company dedicated to the development of drugs and biomarkers for chronic and challenging medical conditions relating to abnormalities of bacterial composition of the human intestine. They have identified and patented biomarkers (originating from metagenomic signatures) associated with disease worsening or drug efficacy prediction. Intestines harbor an incredible number of bacteria, the gut microbiota, encoding 150-fold more genes (the microbiome) than our own genome. Each individual has his own personal and unique microbiota, with a large diversity between individuals. The contribution of the gut microbiota in health and diseases is undisputed, and recent studies demonstrated major alterations of the gut microbiota composition in patients with metabolic and inflammatory bowel diseases.
Private semi-virtual pharmaceutical organization engaged in the discovery and development of novel central nervous system (CNS) drugs, with a primary focus on anti-emetics (anti-vomiting and anti-nausea), anxiolytics and performance sustainment agents (in collaboration with the U.S. Navy and the National Aeronautics and Space Administration-NASA). In October 2012, the Company entered into a Space Act Agreement with NASA and into collaborations with NASA and the U.S. Navy (NAMRU-D) for the development, manufacture, sales and distribution of INSCOP, a new quick-acting intranasal scopolamine formulation. The Company anticipates completion of the remaining clinical studies and delivery of a product for purchase by DoD within 24 months following funding. Concurrent with the development for DoD acquisition, the Company will work with the FDA to move INSCOP into civilian applications for motion sickness and other indications.
Leveraging the power of mobile devices at the point of care to deliver interactive solutions to both patients and providers. We provide a variety of mobile health applications and content using a cloud based application and content management solution. From patient check-in through check-out, we engage the patient and provide tools to enhance the patient/provider experience. We fully integrate with electronic health record and practice management systems to reduce administrative costs and increase efficiencies. We are mobile health at the point of care. Recent News: Epion Health was recently selected by athenahealth as an initial partner in their More Disruption Please initiative. Epion and athenahealth will work together to interface the Epion patient intake and education solutions with the athenahealth electronic health record and practice management software. The goal of the program is to offer the Epion product to athenahealth’s eligible client base of approximately 35,000 physicians.
Eqalix, Inc. is an emerging regenerative medicine development company with a goal of enhancing the quality of life of consumers and patients by providing novel nano-materials for the repair and regeneration of diseased, traumatized, and aging tissues. Their technologies are intended to revolutionize unmet needs in multiple commercial and therapeutic applications in the Regenerative Medicine space.
ETView Medical Ltd. is a public company that has successfully combined airway management with continuous direct airway visualization for medical professionals. ETView’s patented single-use single- and double-lumen tubes consist of a ventilation tube with an integrated continuous high-resolution video imaging system. The company has distribution agreements in North America, South America, Europe, Asia, and Africa.
ExThera Medical is targeting the clinical treatment of blood-borne diseases including bacteremia and sepsis, as well as the removal of harmful substances present in banked human blood and/or caused by contact with man-made materials during cardiopulmonary bypass, dialysis and other extracorporeal procedures.
FluoroPharma Medical, Inc., develops proprietary medical diagnostic imaging products. The company’s initial focus is the development of breakthrough positron emission tomography (PET) imaging agents for the efficient detection and assessment of acute and chronic forms of coronary artery disease (CAD).
Genisphere, LLC manufactures kits for ultra-sensitive detection of nucleic acids and proteins. It offers 3DNA Dendrimers, which are branched molecules that deliver labels for DNA and protein microarrays, microRNA assays, bead-based assays, cellular targeting, and cellular delivery applications. The company also provides array detection products, such as FlashTag kits, which provide ultrasensitive microRNA labeling; FlashTag Biotin HSR, a high-sensitivity microarray labeling kit; Array 50 Kit, a proprietary indirect labeling system for both cDNA and oligo arrays; Array 350 Kit, a proprietary indirect labeling system for cDNA and oligo arrays; Array 900 Kit, a Reagent kit for ultrasensitive gene expression array detection; Array 900MPX, an expression array detection kit; and Array 900DNA, a labeling kit for DNA. In addition, it offers RNA amplification kits; RampUP, a two round RNA amplification kit for intact or FFPE RNA; Sensation Kit, a transcriptome linear amplification kit; and multi-assay signal amplifiers. Genisphere, LLC offers its products through distributors in Australia/New Zealand, Italy, Spain, India, Japan, Taiwan, Korea, Mexico, Venezuela, Brazil, Singapore, Malaysia, South Africa, Hong Kong, China, Israel, Argentina/Chile, the Middle East/Gulf Area, Turkey, and Greece and other Balkan countries. The company was founded in 1997 and is based in Hatfield, Pennsylvania.
Glysure is a medical device company that develops and distributes a system to monitor assist in the diagnosis of glucose related blood illnesses.The GlySure System comprises two main parts, a monitor and a sterile sensor set which includes an integrated fiber-optic sensor/introducer and a fully automated calibration module. The sensor is placed in intensive care patients via a central venous catheter (CVC). As central venous access is required on nearly all ICU patients, the sensor does not require any additional access lines.
Histogenics is a late-stage, privately held regenerative medicine company. They combine cell therapy and tissue engineering technologies to develop innovative products for tissue repair and regeneration. The Company’s flagship products focus on the treatment of patients with active lifestyles who suffer from articular cartilage-derived pain and immobility.
HistoSonics was founded to develop Histotripsy, a non-invasive ultrasound tissue ablation modality that mechanically homogenizes target tissue, resulting in complete cellular destruction within the target zone. The liquefied tissue is absorbed or voided without remnants or scarring. As a non-thermal modality, Histotripsy ablates tissue with NO THERMAL INJURY.
HistoSonics developed its Vortx RX® platform for treatment of Benign Prostatic Hyperplasia (BPH). The Vortx RX Histotripsy system integrates Histotripsy tissue ablation with state of the art ultrasound imaging and procedure planning and tracking software. Because the treatment is non-thermal, there is very little inflammation and tissue margins are very clean, resulting in rapid recovery. These significant advantages were verified in extensive preclinical studies.
An $11million Series A financing funded product development, extensive preclinical studies, clinical protocol preparation and investigator site selection for pilot clinical studies in the U.S. and Canada. HistoSonics recently submitted an IDE (FDA) and ITA (Health Canada) with plans to begin pilot clinical studies in early 2013. Early results from these clinical studies will be reported as the company anticipates closing a $12 – $15 million Series B financing in mid 2013. Series B financing will fund pilot and pivotal clinical studies, PMA submission and OUS market launch.
IMMUNE Pharmaceuticals is emerging leader in developing Monoclonal Antibodies, Ligand-conjugated Nanoparticles (NanomAbs®), and PEGylated Polymeric NanoParticles (PPNs®) based products for a broad range of therapeutic applications, including solid tumors and hematological malignancies, autoimmune, inflammatory and infectious diseases.
ImmunoVaccine Tech. Inc.
ImmunoVaccine Technologies, Inc. (IVT) is a private, clinical-stage company developing breakthrough vaccine vehicles that provide long-lasting immunity with a single administration without significant side effects.
Implandata Opthalmic Products
Implandata Opthalmic Products GmbH is a medical device start-up company, located in Hannover, Germany. The venture capital funded company owns the most superior and robust technology for wireless intracorporal pressure measurement. Implandata Ophthalmic Products GmbH will transform glaucoma care via dramatically better disease information at significant less effort.
InfoBionic is an emerging mHealth company with a proprietary cloud-based SaaS solution, MoMe for comprehensive remote physiological monitoring and analytics. Their vision is to be part of the transformation of healthcare delivery providing anywhere anytime access to monitoring with higher quality and lower cost.
Innara Health, Inc. is an “Series B” stage medical device company focused on developing and commercializing products that are used by neonatal healthcare providers to assess and treat the problem of incompetent feeding in premature infants. With over 500,000 infants born prematurely in the U.S. each year, and as many as half suffering from the inability to adequately breast or bottle feed, there is a compelling need for accelerating the healthy development of oral feeding skills. Delayed development leads to extended stays in the hospital neonatal intensive care unit, creating a substantial medical, economic, and emotional burden on hospitals, patients and their families.
Innova Medical Design
Innova is an early stage company that has developed a pragmatic yet novel solution to alleviate needle pain associated with diabetes and the multiple daily patient lancings required for blood glucose testing and insulin injections.
Intelgenx is a drug delivery company focusing on the development of novel, orally administered drug delivery products based on its proprietary oral drug delivery technologies. The company has positioned itself as a provider of product development services for the pharmaceutical industry, including the branded and generic pharmaceutical markets. Drug delivery systems are an important tool in the hands of physicians for purposes of optimizing drug therapy. For the pharmaceutical industry, drug delivery systems represent an opportunity to extend the market exclusivity and product lifecycle of drugs whose patent protection is nearing expiration.
Interface Biologics, Inc. (IBI) is a privately held commercial stage company that develops transformative biomedical polymer technology to improve the safety and effectiveness of medical devices. Our primary technology focus areas are anti-thrombogenic additives and programmable combination drug delivery devices.
Invion Limited is a clinical-stage drug development company that targets chronic inflammation. The company is focused on the development of treatments for major market opportunities in inflammatory diseases including asthma, chronic bronchitis and lupus. Invion has two phase II proprietary therapeutic candidates: INV102 – a repurposed inverse beta agonist; and Cpn10 – a modified natural immunomodulator.
IR2Dx ‘s novel diagnostic tests enable physicians to greatly improve detection and outcome for patients developing or suffering from diabetes, atherosclerosis, and related diseases. We are the leader tying together patient condition, test results, and treatment guidance in this field. IR2Dx tests enable effective treatment of the causes, stopping or delaying disease, and are used for all stages of disease, from prediabetes to late stage diabetes.
ISTO Technologies, Inc.
ISTO is a private company developing innovative cartilage and bone regeneration products for spinal therapy, sports medicine and trauma. They specialize in Orthobiologics, Medical Device, Products for Spine and Orthopedics, Cell-Based Pipeline, Injectable Cell Therapy, Regenerative Medicine, Minimally Invasive Spine and Orthopedic Solutions, Living Cartilage Implants, Spinal Disc Regeneration.
ITI-Group is a diversified company. The core of ITI-Group is focusing on tech-knowledge, tech-novation and tech-solutions. ITI-Group is engaged in the combination business fields of IT and internet; medical, pharmaceutical and bio-technology; technology assessment, technology and property-exchange, bidding and auction; as well as other consulting services. ITI-Group is an international corporation its business and transactions covering many countries especially developing countries. ITI-Group does many international trade deals arranging from manufacturer, international shipment, import and export and distribution. ITI-Group has started business since early 1990s. The goal of ITI-Group business is to provide high quality products, better services and good solutions for our customers.
MEDomics provides Mutation Expert-based Diagnosis (“MED”) of patients’ genome data to enhance personalized medicine through the employment of bioinformatics, clinical genetics, and mutation
Neuromodulation is the second-oldest and fourth-largest of Medtronic’s business units. It was formed as we transferred our expertise in heart electrical stimulation to treat diseases and conditions involving the nervous system. Today, our products include neurostimulation systems and implantable drug delivery systems for chronic pain, common movement disorders, and urologic and gastrointestinal disorders.
Mercator MedSystems, Inc. is a private medical technology company focused on the treatment of hypertension utilizing its catheter-guided, microfluid injection systems for site-specific, non-systemic delivery of therapeutic agents directly across any blood vessel. The Company’s Cricket™ and Bullfrog® Micro-Infusion Catheters are the first vascular-access systems able to inject drugs, genes, and cells safely through vessel walls into deep tissues without major surgery.
Metabiomics is an early stage, private, molecular diagnostics company that is developing products and services based on advances in human microbiome metagenomic sciences.Metabiomics has been an early innovator and leader in the development and application of microbial ecology and metagenomic sciences applied to human microbiome biomarker discovery and clinical research since 2004.Metabiomics provides specialized DNA sequencing and metagenomic research services to support scientific and clinical research of the Human Microbiome.
Micro Interventional Devices
Micro Interventional Devices (MID) is an early stage medical device company that designs, manufactures and commercializes disruptive technologies for use in percutaneous and minimally invasive structural heart repair procedures.
MiMedx Group, Inc.
MiMedx Group, Inc. is an integrated developer, manufacturer and marketer of patent protected biomaterial-based products. The company is successfully emerging from a development-focused start-up phase into a fully integrated operating company with expertise to capitalize on its science and technology and its capacity to generate sales growth and profitability.
Miracor Medical Systems GmbH is developing and commercializing a new technology called Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO®) to improve outcomes in acute coronary syndrome, heart failure, and cardiac surgery patients.
Monteris Medical, Inc.
Monteris Medical Corporation is a privately held medical device company dedicated to the development of minimally invasive, MRI-guided neurosurgical solutions. They strive to provide options for surgeons treating brain cancer.
NanoViricides Inc. is a pre-clinical biotech company that develops drugs to combat viral infections. The Company designs “nanoviricides” that fool viruses into attaching to them in that same way that viruses typically attach to the receptors on a cell surface. The Company has drug candidates against HIV, seasonal influenzas and bird flu, herpes, viral eye diseases, and dengue viruses, and has nominated a clinical candidate in its FluCide™ program.
NeoControl is a privately held medical device company. developed a novel non-invasive neuro-muscular stimulator of the pelvic floor (called “Neocontrol”), as a treatment for a variety of disease states. The Company has multiple patents approved, pending, and in preparation.
NeuroMetrix is a medical device company focused on the neurological complications of diabetes. Its products consist of medical devices and consumable biosensors. The Company believes that there are significant unmet needs in the diagnosis and treatment of diabetic neuropathies.
Oragenics is a biopharmaceutical company focused primarily on oral probiotics products and novel antibiotics for humans and companion pets. Within oral health we are commercializing our patented probiotic blend, ProBiora3® specifically formulated for oral health both under our branded Evora line and in private label configurations.They have sales or contracts to sell these products in over 15 countries around the world. The focus on the probiotic area will be to grow sales through a variety of channels including internet sales and the professional channel (dentists and hygienists) as well as through private label and bulk sales of our patented ProBiora3 blend.
Oxygen Biotherapeutics, Inc. is developing medical and cosmetic products that efficiently delivery oxygen to tissues in the body. The company has a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier that is being formulated for both intravenous and topical delivery.
Pressure Cycling Technology (PCT) is a public company that uses rapid cycles of hydrostatic pressure between ambient and ultra high levels to control biomolecular interactions, allowing for a high degree of precision, reproducibility, convenience, speed, and safety. This unique, patented technology offers the potential for broad applications in a number of established and emerging fields, including genomics, proteomics, drug discovery & development, process purification, pathogen inactivation, immunodiagnostics, and DNA sequencing.PBI focuses on the development and sale of PCT-enhanced enzymatic digestion products designed specifically for the mass spectrometry marketplace, as well as sample preparation products for biomarker discovery, soil and plant biology, forensics, histology, and counter-bioterror applications. PBI currently holds 13 US and 6 foreign patents covering multiple applications of PCT in the life sciences field, including genomic and proteomic sample preparation, pathogen inactivation, the control of chemical (primarily enzymatic) reactions, immunodiagnostics, and protein purification.
Response Biomedical Group
Response Biomedical is commercializing a new class of diagnostic with the world’s only immunoassay platform that provides lab quality information in a matter of minutes, anywhere, every time. RAMP tests are commercially available for three cardiac markers used in the early detection of heart attack, environmental detection of West Nile virus, and biodefense applications.
Radisens Diagnostics Ltd
Point-of-Care platform integrating multiplexed immunochemistries, cell counting and clinical chemistries with 3rd generation pico-gram sensitivity for instant monitoring of chronic disease using a finger-prick of blood. Initial panels include diabetes, kidney, thyroid, heart disease and cell counting tests.
Ridge Diagnostics is a neurodiagnostic company that offers a proprietary first-in-class blood test for Major Depressive Disorder (MDD).
Salvetis robotics is a revolutionary platform that advances surgical technology. It empowers surgeons to provide keyhole surgery beyond the limits of human capability, at a lower cost, whilst dramatically expanding the numbers of procedures that are performed daily. That is because it is the first robotics platform that acts, feels , and mimics skills of the world’s finest surgeon. And it does so whilst potentially saving healthcare providers billions of dollars per year. Salvetis purpose is to make keyhole surgery universally accessible to all. Salvetis is headquartered at Cambridge in the United Kingdom.
S.E.A. Medical Systems
S.E.A. Medical Systems Inc. is a private healthtech company that pioneers smart solutions for the safe manufacture, preparation, delivery, and disposal of intravenous and other liquid medications. The Company’s medical devices catch life-threatening IV drug errors before they harm patients.
Soft Tissue Regeneration, Inc.
Soft Tissue Regeneration Inc. is the first to create a bioengineered matrix that completely regenerates the ACL. STR has also submitted a 510(k) application for soft tissue augmentation and rotator cuff repair device.
Stroma Medical Corporation
Stroma Medical is a late development stage medical device company. Stroma uses a proprietary laser system to safely and effectively change the color of peoples eyes from brown or hazel to blue or green. The company has patents issued and pending.
Synthetic Biologics is a biotechnology company focused on the development of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses. Target indications include pulmonary arterial hypertension (PAH), relapsing-remitting multiple sclerosis (MS), cognitive dysfunction in MS, fibromyalgia and amyotrophic lateral sclerosis (ALS).
Targeted Medical Pharma, Inc.
Targeted Medical Pharma, Inc., is a publicly-traded biotechnology company that develops and sells prescription Medical Foods. The Company also distributes generic and branded pharmaceuticals to physicians, pharmacies and skilled nursing facilities. The Company’s Medical Food products are used in the treatment of pain syndromes, obesity, hypertension, immune disorders, sleep and cognitive disorders. TMP has been awarded more than $733,429 in government grants for it research associated with pain, cognitive and sleep disorders. Randomized Double Blind Clinical Trials involving TMP’s products have shown that when certain Rx Medical Foods are used in conjunction with pharmaceutical agents, efficacy is improved and the negative side effects associated with the non-Medical Food pharmaceuticals are potentially reduced. Medical Foods supply the body with the necessary amino acids to make specific neurotransmitters. Neurotransmitters are the chemical messengers that allow one neuron to communicate with other neurons or effector organs. Presenters: William Shell, M.D. and David Silver, M.D.
Tensys Medical, Inc.
Tensys Medical, Inc. is focused on improving patient safety by designing, manufacturing and marketing a continuous, non-invasive blood pressure monitoring system.
Tissue Regeneration Systems
Tissue Regeneration Systems (TRS) is a start-up medical device company commercializing a breakthrough skeletal reconstruction and bone regeneration technology platform licensed from the Universities of Michigan and Wisconsin. Their technology has been evaluated in several large animal studies with very promising long term results. We have conceptualized initial product offerings, completed all required bench and animal testing, and filed our first regulatory submissions to the FDA. Approval of these submissions will allow TRS to commercialize products in the United States and we expect to begin generating meaningful revenues in the next two to three years. Presenter: Jim Fitzsimmons, Management: Jim Fitzsimmons, President and CEO.
TNI Biotech, Inc.
TNI Biotech, Inc. develops immunotherapies for the treatment of cancer, HIV / AIDS and autoimmune diseases using methionine enkephalin (MENK) and Low Dose Naltrexone (LDN). Formed in 2012, TNIB in the last year has published in a number of international journals the results involving MENK, observing: that MENK inhibits regulatory T cells which is a key in cancer therapy; and that MENK showed more advantages than Interleukin -2 (IL-2) or Interferon-γ (IFN-γ), two widely known cytokines. TNIB is has completed Phase I and Phase II trials in China, researching the use of leukaphoresis with MENK in clinical trials in China. Patents filed in China in 2009 were approved in 2011. TNIB expects to file the USA patent in the coming months.
UE Life Sciences
UE LifeSciences is medical device company focused on Women’s Health. They commercialize and developed an effective, low-cost and easy-to-use breast cancer screening solutions suitable for diverse range of demographics and healthcare systems around the world. NoTouch BreastScan™ is a touch-less and radiation-free infrared imager.
Vaccinogen is a late stage, private biotechnology company with more than three decades of research into combating cancer by using the body’s own immune system. It is the producer of OncoVAX®, the only immunotherapy for Stage II colon cancer. The company maintains a European subsidiary in Emmen, The Netherlands that operates a fully functioning cGMP manufacturing center for the production of OncoVAX® vaccine.Vaccinogen is also focused on discovering, developing and manufacturing fully human monoclonal antibodies for human clinical use. Its HumaSPECT antibody was one of the first to be widely approved for any clinical use worldwide. They are developing other products based on work in colon carcinoma, renal carcinoma and melanoma.
VertiFlex is dedicated to the advancement of minimally invasive solutions that resolve the pain of lumbar spinal stenosis (LSS). VertiFlex has developed a proprietary interspinous access platform for performing both indirect and direct decompression of the lumbar spine.