Archives for November 2008
Terminated: Minrad International Ends Agreement with RxElite
Minrad International has terminated its distribution agreement with RxElite. The action was taken after the RxElite failed to pay $5.6 million in accounts owed to Minrad.
Prior to September 2008, RxElite had held the exclusive distribution rights for Minrad produced anesthetic gases in the U.S. human market. That agreement covered Sevoflurane, the most commonly used anesthetic gas in the U.S., and Isoflurane, another widely used anesthetic.
Dave DiGiacinto, President & COO of Minrad, commented, “[We] have had ongoing dialogue for several months with RxElite’s senior management in attempt to work out an acceptable payment plan…unfortunately we were unsuccessful in this effort, and failed to find alternative ways to work together in the U.S. Marketplace.”
Minrad is exploring potential legal actions even as it wrestles with more pressing issues. The company, after an abominable third quarter, announced it would layoff 35 percent of its workforce.
Mike Landess’ Battle with Prostate Cancer
A quick shout to Mike Landess, a Denver, CO newsman who this week released a half hour DVD special on prostate cancer (check out his blog).
Mike was diagnosed with the disease in November 2006. The DVD, Prostate Cancer: My Story, chronicles every step of Mike’s journey from diagnosis, to doctors’ visits, to his current status. We met Mike in October while filming a documentary on Focal Therapy.
Prostate Cancer: My Story is available to the public at no charge care of the Prostate Cancer Education Council, a non-for-profit that aims to increase awareness of prostate cancer screening and treatment options. To obtain a copy, visit www.pcaw.com or call 303-316-4685.
[Video Profile] Interview with Michael Fons, VP Corporate Development at Inovio Biomedical
Inovio Biomedical’s electroporation technology uses brief, controlled electrical pulses to increase cellular uptake of gene expression in DNA-based treatments; this enhances the potency of DNA-based immunotherapies against cancers and infectious diseases.
Inovio has an extensive patent portfolio and line of devices and prototypes for electroporation-based DNA delivery. Interim clinical data from multiple studies has indicated safety and tolerability, heightened levels of antibody and T-cell immune responses, and durable local and systemic tumor responses – providing initial validation of electroporation’s ability to enhance DNA vaccine potency.
The company licenses its technology and works through collaboration. Current partners include:
- Merck (cancers)
- Wyeth (infectious diseases)
- HIV Vaccine Trial Network (HIV)
- National Cancer Institute (HIV)
- International AIDS Vaccine Initiative (HIV)
- Vical (metastatic melanoma)
- Moffitt Cancer Center (malignant melanoma)
- University of Southampton (prostate cancer)
AngioDynamics: Irreversible Electroporation Shows Early Promise
AngioDynamics announced the first percutaneous use of NanoKnife, an irreversible electroporation (IRE) device. Although its too early to estimate the product’s prospects, under AngioDynamics watch, IRE has blockbuster potential. Synergies with the company’s other oncology products (which use radio frequency energy to destroy target tissue) abound.
Irreversible electroporation uses electrical fields to create small defects in a cell’s membrane. Damage to the cell membrane causes cell death but spares surrounding structures like blood vessels and nerves. By lessening collateral damage and sparing surrounding structures, the body is better able to remove damaged tissue. AngioDynamics acquired the technology from Oncobionics in April 2008.
“With IRE, what I believe we’re looking at is a whole new treatment modality that can be used on a wider spectrum of patients which potentially reduces risk or impact to their body. I believe the NanoKnife represents a new paradigm in radiologically
Trod Medical: FDA 510(k) Clearance for Encage
Trod Medical has received FDA 510(k) clearance for Encage, a minimally invasive technology for soft tissue ablation. The surgical system allows for precise percutaneous ablation of target tissue with well-defined margins, helping spare healthy surrounding tissue.
Encage electrodes are inserted percutaneously and guided using ultrasound imaging. The electrode is viewed in real time via the ultrasound image while being precisely positioned into the target tissue. Encage may be used with a stand-alone, proprietary software for surgical planning and image guidance during the procedure. A RF-bipolar generator precisely controls the ablation.
The company expects to ship product for the initial human clinical trials in the first quarter of 2009. The device has potential applications in prostate, kidney and liver cancer treatment.
Liquidity Crisis: Minrad International Slashes Jobs, Evaluates Options
In an effort to improve its cost structure and conserve cash, Minrad International said it would layoff 35 percent of its workforce, or some 50 jobs. The layoffs come after a dismal third quarter. Despite revenue growth, the company’s net loss widened to $10.8 million, double last year’s third quarter loss.
Starting in May, Minrad successfully implemented a growth strategy to support its core international anesthetic business. All program and discretionary spending was redirected to this business unit. Says Dave DiGiacinto, Minrad’s President and COO, “The demand for our core anesthetic business continued to grow in the third quarter of 2008, especially in international markets. This was evidenced by our international shipments, which were up 271% over the third quarter, 2007.”
Even with heightened demand, the lack of liquidity plagued Minrad. Last quarter, the company was unable to secure the raw materials needed
SyntheMed: FDA Clearance for SinusShield
SyntheMed, of Iselin, NJ, has received FDA 510(k) clearance for SinusShield, a bioresorbable membrane to prevent post-operative adhesions from forming after nasal and sinus surgeries.
It’s common for surgeons to place silastic tubes or sheets in the sinus passages to prevent blockage caused by scar tissue. However, these materials must often be removed during a second procedure. SinusShield is intended to prevent blockage and then biodegrade.
SyntheMed is now in talks with prospective distribution partners who would service the office-based and hospital outpatient sites where these surgeries are performed. There are approximately two million nasal and sinus procedures performed annually in the U.S.
“SinusShield represents an example of our strategy to capitalize on our proprietary polymer film technology in new surgical applications both in the United States and international markets,” said Robert Hickey, SyntheMed’s President and CEO.
Previously: SyntheMed Raises $4 Million
Candela Buys Some Time
Shares of Candela Corporation, a maker of aesthetic lasers, jumped 31% yesterday after the U.S. District Court agreed to postpone the patent litigation suit brought by Palomar Medical in August 2006.
Candela filed a motion requesting a stay on October 31st after the company learned that that a reexamination request had been filed with the U.S. Patent and Trademark Office. While requests for patent reexamination are common, the process takes an average of 24.3 months according to Patent and Trademark Office statistics.
The postponement will buy Candela much needed time to explore strategic alternatives. Gerard Puorro, Candela’s CEO, commented, “While, the reexamination is pending, we expect a precipitous drop in our legal expenses while we work to restore profitability to the company.”
In its most recent quarter, revenues at Candela decreased 24 percent (year-over-year) to $26.9 million. The company reported a net loss of
OneMedForum 2009: Finance Conference for Emerging Med Tech Companies
The OneMedPlace finance conference for emerging med tech companies, the OneMedForum, will be held January 13-14 in San Francisco. Click here to learn more.
San Francisco, in early January, is the place to be if you’re in the healthcare industry. Thousands of industry executives and investors will be attending JP Morgan’s Healthcare Conference.
The OneMedForum occurs simultaneously with that event, but we are unique in that we focus on emerging private companies and small cap public companies.
The event includes industry-focused panel sessions and numerous networking opportunities. Over fifty of the most promising companies will be making formal presentations.
If you are an investor looking to identify “the next big thing” in med tech, or the chief executive of an emerging company, this conference is for you. Click here to register (registration has been strong and we expect to reach capacity soon).
Finally, we have a
Escalon: Expansion Efforts Impact Gross Margins
Escalon Medical managed solid revenue growth its first fiscal quarter of 2009. The company reported quarterly revenues of $8.7 million, compared with $6.9 million in the same period last year. The increase was primarily due to the acquisition of JAS Diagnostics in June.
Escalon operates through several wholly owned subsidiaries: Sonomed, Escalon Digital Solution, Trek, Escalon Vascular Access and Drew Scientific. The companies offer medical devices and pharmaceuticals in the areas of ophthalmology, diabetes, hematology and vascular access.
All of these subsidiaries experienced year-over-year growth with the exception of the Trek business unit – sales there were off 16%. Trek offers an aging line of Ispan Intraocular gases and fiber optic light sources.
In the near term, the company remains committed to growth. The company has received five new FDA clearances since July 2007. Escalon’s Sonomed subsidiary is planning to launch three new products
