Medical Device Daily Contributing Writer

SAN FRANCISCO – The next “big thing“ in healthcare? Pico-Tesla (Littleton, Colorado) CEO Allen Braswell believes it will be Magneceutical Therapy. Jon Hoem, CEO of Miracor Medical Systems (Vienna, Austria), believes it will be PICSO (Pressure-controlled Intermittent Coronary Sinus Occlusion). Then again, RepRegen (London) CEO Ian Brown believes it will be the company's 'smart biomaterials,' designed both to support and to improve cellular growth in vivo. And then there's Ovatech (Auburndale, Massachusetts), whose CEO, John Williams, is bullish about Ovaprene, a one-size-fits-all vaginal ring barrier contraceptive device designed to release a non-drug spermiostatic and spermicidal agent.

All four CEOs presented their company's story at the fourth annual OneMedForum 2011 finance conference for emerging healthcare and life science companies, which convened at the Sir Francis Drake Hotel in San Francisco last week. According to Brett Johnson, founder and CEO of OneMedPlace, organizer of the conference, the OneMedForum meeting attracted 20% more participants than the 1,000-strong crowd at last year's event, including: medical device entrepreneurs, venture capitalists, private equity investors, corporate strategic investors, investment bankers, research analysts, financial and investment advisors, and brokers.

Pico-Tesla is in the midst of four clinical studies that CEO Braswell says will be completed this year. These studies are using magnetic resonance technology produced by the company's Resonator system and proprietary Magneceutical Therapy protocols. A Phase III pivotal clinical trial in Parkinson's Disease is being conducted at three sites; after completion, a 510(k) submission will follow. The Resonator is a non-invasive, non-significant risk technology platform that generates a low-level electromagnetic field (EMF) that is designated a 'Non-Significant Risk' by the FDA.

Pico-Tesla's “Software as a Service“ (SaaS) model is designed to create recurring revenues, says Braswell. Neurologists pay for treatment sessions that are downloaded via access of Pico-Tesla's website. “We have a strong lead product in one of the fastest-growing sectors of healthcare,“ says Braswell. “Neuromodulation, which is electrical or electromagnetic stimulation of the body, is projected to be a $4.5 billion worldwide sector of healthcare by 2012. We're focused on large existing markets. The PD market alone affects more than 1.5 million persons in the U.S., with 60,000 news cases diagnosed annually,“ Braswell says. “We have multiple exit alternatives.“

With a technology platform and at least one commercial product, Pico-Tesla would be an attractive partnering candidate, according to Braswell. The company has nearly completed its Series A round and expects to commercialize the first of its products in 2012.

Miracor Medical Systems is commercializing a unique and potentially disruptive technology as well, called PICSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) for acute coronary syndrome (ACS, or heart attack), heart failure, and cardiac surgery patients. According to CEO Hoem, Miracor's objective is to establish PICSO as the standard of care for heart attack patients, thereby improving their quality of life. The initial market opportunity for PICSO, says Hoem, is 30% of all ACS patients treated per year, which translates into more than 350,000 patients in the U.S. and Europe.

Hoem says that PICSO solves a significant unmet clinical need. “Timely myocardial reperfusion using primary percutaneous coronary intervention (PCI) remains the most effective treatment strategy for limiting infract size, reducing left ventricular remodeling and improving clinical outcomes following ST-segment elevation myocardial infarction (STEMI),“ says Hoem. “But despite optimum primary PCI, the mortality and morbidity following a STEMI event remains sizable. Clearly, primary PCI alone is not enough to eliminate the risk for future cardiovascular events.“ Miracor's PICSO device, according to Hoem, offers a new and innovative approach to reduce myocardial injury and to revitalize ischemic myocardium. Initial clinical results show positive effects on MACE, restenosis rates, and long-term event-free survival.

Miracor has already received European approval CE-mark for its PICSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) Impulse System, designed to improve acute coronary syndrome (ACS) revascularization following primary percutaneous coronary intervention (PCI). The CE-mark allows European interventional cardiologists to use the PICSO Impulse System during coronary revascularization procedures following myocardial infarction and other types of acute coronary syndromes to intermittently increase the pressure in the coronary venous system. The next phase, “crossing the technology adoption chasm,“ says Hoem, will focus on validating clinical utility of PICSO in 7 leading European centers participating in the randomized, multi-center RAMSES trial in ST-segment elevation myocardial infarction (STEMI) patients. Clinical endpoints for initial U.S. regulatory activities will be incorporated into the RAMSES trial protocol. Full launch in Europe and commencement of preclinical trials in the U.S. are targeted in 2013 based on clinical evidence and KOL support established by the RAMSES investigators and other early adopters, according to Hoem.

RepRegen positions itself as the 'smart biomaterials' company, according to CEO Brown. RepRegen recently raised additional capital led by existing investor Imperial Innovations and included Longbow Capital and other investors. Proceeds, says Brown, are being used for research and product development programs; progressing of patent applications; product regulatory approvals; commercialization programs; preparing for clinical studies; and working capital through to a Series A funding round planned for 2011.

A spin-out company from Imperial College London, headquartered within the Imperial College Incubator, RepRegen is poised to commercialize the initial product of its hard tissue repair and regeneration platform targeted for orthopedic (trauma, spine) and craniomaxillofacial applications. The company recently received CE mark approval for StronBone bone graft substitute bioactive glass with Strontium, the first product that will be commercialized from RepRegen's repair-and-regeneration platform of 'smart' biomaterials for hard tissue.

Ovatech, too, believes that it has enormous potential. “Our lead product, Ovaprene, based on our patented vaginal 'ring' platform, is a one-size-fits-all contraceptive device designed to release a non-drug spermiostatic and spermicidal agent,“ says CEO Williams.

The Ovaprene ring is designed to be inserted and removed by women as desired, says Williams, without the need for insertion by a medical professional. In phase I and phase II clinical studies, the Ovaprene ring was shown to be safe and effective compared to other barrier contraceptives, and well-tolerated by users and their sexual partners. According to Williams, the FDA has indicated that the pivotal phase III study will only be 6 months in duration. FDA has also indicated that Ovaprene will be regulated and evaluated as a device, not as a pharmaceutical. Ovatech expects to complete the phase III study including required follow-up during calendar 2011.

The phase I Ovaprene study involved 20 patients and was conducted at New York Downtown Hospital (NYDH). Patients inserted the Ovaprene ring after menses and removed it prior to the next menses. All rings remained in place and post-coital examinations demonstrated high contraceptive efficacy, says Williams. Participants and their sexual partners indicated they would use Ovaprene again and would recommend it to others. No adverse events were reported, and the results of the phase I study were published in the Nov.-Dec. 2009 issue of the Journal of Reproductive Medicine.

The phase II Ovaprene study involved 85 patients and was also conducted by NYDH and completed in August 2010. Results were consistent with the phase I study, Williams says, with Ovaprene being very well-tolerated by sexually active women. Efficacy was shown to be superior to other barrier contraceptives, according to Williams. In particular, in the phase II study, Ovaprene demonstrated efficacy that was superior to contraception using a diaphragm plus spermicide. No adverse events were reported. As in the phase I study, participants indicated they would use Ovaprene again and would also recommend it to others,“ according to Williams. Preliminary phase II results were presented at the May 2010 meeting of the American College of Obstetrics and Gynecology (ACOG; Washington).

Williams says that Ovaprene offers significant advantages over other barrier contraceptives. Unlike diaphragms, Ovaprene does not require fitting and insertion by medical personnel and is a “one size fits all“ device. Ovaprene can be removed by women whenever desired. Ovaprene does not use hormonal agents and therefore avoids side effects associated with hormonal birth control, which can include loss of libido, vaginal infections, headaches and nausea. Bacterial and viral transmission, which have been reported with contraceptive sponges, were not observed in Ovaprene clinical studies, says Williams, who further noted that a recent study conducted by the University of Chicago indicated that barrier contraceptives promote a higher level of compliance among users compared to oral contraceptives. “As a female-controlled, non-hormonal, non-drug barrier contraceptive device, Ovaprene is well positioned to capture a significant portion of the barrier contraceptive market and to attract users of oral contraceptives as well,“ insists Williams. “The importance of Ovaprene as non-hormonal, coitus independent contraceptive device cannot be overstated.“

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