Archives for April 2008
NeuroMetrix Receives FDA 510(k) Clearance for Advance
Long beleaguered NeuroMetrix, which has seen its stock price erode as officials investigate the marketing and misuse of its NC-stat System, received FDA 510(k) clearance for the Advance System this week. Shares of the Waltham, MA-based company nearly doubled on the news, to a high of $3.06 on Monday.
Advance is a platform for performing nerve conduction studies and invasive electromyography procedures. The device incorporates an electrical stimulator and dual recording channels for acquiring nerve conduction responses (a third channel is available for recording needle electromyography signals).
Advance distinguishes itself with its low cost, small size, high capacity lithium-ion battery, and embedded amplification and digitization hardware, which reduce the potential for electrical interference. The company believes Advance is well-suited to a multitude of settings, including nerve function assessment in intensive care units.
NeuroMetrix will market Advance to neurologists, physical medicine and rehabilitation (PM&R)
[Video Profile] Interview with Dr. Randal Chase, CEO of ImmunoVaccine Technologies
ImmunoVaccine Technologies (IVT) is a private biotechnology company developing therapeutic cancer and infectious disease vaccines.
VacciMax technology is based on a novel approach to the use of liposomes. While liposomes typically contribute only marginally to the production of an immune response, IVT has discovered that liposomes stabilized by VacciMax technology significantly enhance antibody production.
The company believes VacciMax will have the greatest impact in therapeutic cancer applications by stimulating earlier, more powerful, and longer lasting immune responses.
An End to Three Dose Vaccine Regimens?
In a variety of human infectious disease and cancer models, a three dose regime of vaccine can be reduced to one by reformulating the antigens in VacciMax. The single dose capability of VacciMax was demonstrated in therapeutic cervical cancer and melanoma challenge models using weakly immunogenic peptides as antigens. IVT has demonstrated that VacciMax improves both humoral and cell-mediated response.
With this
Merit Medical: Shows Resilience in Faltering Economy; Positioned for Continued Growth
The healthcare equipment sector has a history of resilience. The sector remained strong during the economic downturn earlier this decade and appears to be holding its own now. An aging demographic virtually guarantees increased demand for healthcare supplies.
Not surprisingly, the sector is also highly competitive. J&J, Boston Scientific and Medtronic are industry behemoths with a combined market capitalization exceeding a quarter of a trillion dollars.
Despite the competition these firms present, Merit Medical, a provider of disposable devices used primarily in cardiology and radiology procedures, has managed to grow and prosper. Last week the company announced a 50% increase in earnings per share to $.15 from $.10 in Q1 2007.
Merit is a market leader in many of the products it offers, 72% of which are sold within the U.S. (41% are sold directly to U.S. hospitals). The company has managed to
Yulex Receives FDA 510(k) Clearence for Novel Rubber Glove
Latex glove use increased dramatically in the eighties largely as an outgrowth of the AIDS epidemic. Almost unheard of 20 years ago, researchers now estimate that 8% - 12% of healthcare workers have developed allergies to traditional latex.
In one well-cited study of blood donors, more than 6% had evidence of latex antibodies. Extrapolated to the U.S. population, more than 18 million Americans may have developed latex sensitivity. Severe reactions can include difficulty breathing, itching, rash, hives, and in some rare cases shock and death.
Yulex Corporation has developed examination gloves with patented Yulex rubber, made using guayule, a desert crop native to the U.S. Southwest. Yulex does not contain the allergic reaction-causing proteins seen in traditional latex products which use the milky sap of a rubber tree, Hevea braziliensis.
The company has the exclusive license on a patent from the U.S. Department of Agriculture
Biophan Moves Forward with Myotech CSS Development
Pittsford, NY-based Biophan Technologies, will move forward with the next phase of the Myotech Circulatory Support System (CSS) engineering and regulatory development program.
The company’s board released $2 million to support efforts which will bring the product closer to commercialization. According to the company, Myotech CSS could be on the market within 24 to 30 months.
The Myotech CSS addresses a significant unmet need – acute circulatory support for patients suffering from sudden cardiac arrest. Today in the U.S., over 260,000 patients suffer in-hospital cardiac arrest every year, and about 80% of those patients do not survive.
The Myotech CSS consists of an external console and flexible polymer cup that slips over the heart and is designed to restore normal blood flow. It can be deployed quickly for use in acute resuscitation and low cardiac output patient conditions. Myotech CSS, unlike other circulatory
OccuLogix Looks to Tears, Hopes to Survive Difficulties
OccuLogix, which traded as high as $1.63 just one year ago, has seen its share price erode as investors lose confidence in the company and its management. OccuLogix has consistently failed to execute general corporate strategy. The company, which faces NASDAQ delisting, opened at $.22 this morning.
In 2007, the company’s recorded a net loss of $68.1 million, or $1.20 per share. Revenues from continuing operations were $94,500. At year end, the company had $2.2 million in cash on hand.
- In September, 2006 OccuLogix acquired SOLX, developer of the SOLX Glaucoma Treatment System. It subsequently sold SOLX in December 2007. The company’s glaucoma business has since been classified as ‘discontinued operations’.
- In November 2007, OccuLogix suspended (indefinitely) a study begun in January 2007 to evaluate the safety and efficacy of the RHEO System. The RHEO procedure treats Dry AMD with apheresis, a treatment
Maryland Medicaid Approves ActiPatch Technology for Kidney Compromised Patients
Patients with kidney disease often avoid common pain relievers like aspirin, ibuprofen and naproxen. These medications have the potential to exacerbate existing conditions and create life-threatening drug interactions. As an alternative to drug-based relief for kidney-compromised patients, Maryland Medicaid will now offer reimbursement for BioElectronics’ ActiPatch.
ActiPatch is a drug-free anti-inflammatory patch which accelerates healing while reducing soft tissue pain and swelling through the use of pulsed electromagnetic frequency (PEMF) therapy. The thin patch uses an embedded battery to deliver continuous pulsed RF therapy to an injury site.
Watch this video (featuring what appears to be an animatronic host) to learn more.
ActiPatch was cleared by the FDA for the treatment of edema following blepharoplasty, a procedure in which the physician surgically removes excess fat, muscle, and skin from both the upper and lower eyelids. The device is also approved in Canada and
[Video Profile] Interview with Leah Sparks, VP Business Development of DNA Direct
Medical professional societies have mandated that genetic tests be ordered by a physician and interpreted by a genetic counselor, geneticist, or other specialist. In some states, genetic testing must be accompanied by an in-person genetics evaluation or genetic counseling appointment.
This approach is limited by the fact that there are only 1,200 medical geneticists and just over 2,000 genetic counselors in the U.S., most of whom live in urban areas. In our existing healthcare model, not everyone has access to genetic testing that that can help encourage informed decision making.
San Francisco-based DNA Direct has created a web- and phone-based virtual genetics clinic. Genetic testing results can be complex, and inmost cases, do not provide definitive “yes” or “no” answers. DNA Direct focuses on personalized test result interpretation and supportive services.
The company provides individuals with education and the opportunity to decide whether testing
CryoLife to Distribute Medafor Hemostatic Agent
CryoLife, in a three-year agreement signed last week, will become the exclusive U.S. distributor of Minneapolis, MN-based Medafor’s microporous polysaccharide hemostatic (MPH) agent for use in cardiac and vascular surgeries.
CryoLife will also offer MPH outside of the U.S. (excluding Japan and China) in cardiac, vascular and general surgical procedures but not in orthopedic or ENT procedures.
The hemostat received CE Mark approval in 2003 and FDA pre-market approval in September 2006; it will be distributed by CryoLife under the private label name Hemostase MPH.
Hemostase rapidly dehydrates blood, enhancing clotting on contact. Available in a ready-to-use applicator, the flowable powder facilitates the formation of a natural clot within minutes.
Pre-clinical evaluations have shown that Hemostase MPH does not promote infection and absorbs within 24-48 hours of application at the wound site, compared to other surgical hemostats which can take 3-8 weeks to fully
Boston Scientific to Acquire CryoCor
Boston Scientific will acquire CryoCor for $17.6 million in cash or $1.35 per share. The buyout comes after a tumultuous year for the San Diego-based company; CryoCor stock traded as high as $7.20 prior to regulatory difficulties.
CryoCor suffered a blow in June when it learned that FDA was unhappy with its pre-market approval (PMA) application for its Cryoablation System, which uses extreme cold to treat cardiac arrhythmias. It was the second time the FDA has found fault with the company’s device. In 2006, the FDA rejected the CryoCor’s PMA application, prompting the company to amend and resubmit in November 2006.
In August, CryoCor received, at last, the okay from the FDA. The Cryoablation System was approved for the treatment of right atrial flutter, a condition where the upper chambers of the heart beat too fast.
Later that month, CryoCor completed enrollment of the pivotal clinical
