With U.S. regulatory approval in hand, Medasys is seeking investors to help fund the commercial launch of its programmable implantable drug pump to treat pain, MedCity News is reporting.
The Mount Olive, NJ, device startup announced Feb. 13 that the FDA granted premarket approval for its Prometra programmable pump, which is designed to be streamlined and more efficient, and the first major advance in the field for the U.S. market in about 15 years. Device giant Medtronic ($MDT) can take credit for the last big advance, according to the MedCity article.
CEO Steve Adler explained to MedCity that the pump uses "pressure differentials" to make sure the drug delivery is accurate, even as it has no motors or tubing and very few moving parts. Doctors implant it in the lower abdomen. The pump delivers the pain medication Infumorph through a catheter from the device itself to the spine, using a "gated precision dosing system" that manages dosing variations based on temperature, pressure, flow rate or how much of the drug remains in the pump reservoir, according to the company.
And here we have our storyline. We'll cast Medasys as "David" and Medtronic as "Goliath." Prometra is Medasys' first product approved in the U.S. (the pump gained a CE mark in Europe in 2010). Medasys aims high, however, with its public relations material, claiming in its FDA announcement to have the strategic goal of "becoming the leading implantable drug delivery company in the world."
Medtronic has long had a presence in the space, with products such as the SynchroMed II Drug Pump for pain. But as FierceMedicalDevices told you in July, even as doctors have implanted more than 139,000 of the pumps globally, Medtronic cautioned that a small number of the pumps have a potential for substandard battery performance. So disgruntled medical customers might open the window for at least a small dent into Medtronic's market dominance.
Remember, no one thought David could beat Goliath, but look what happened there. To be continued...
- here's the release
- read the MedCity News story