There is no off-time if you're working for a small med-tech start-up, seeking to secure funding in this economy. Those in question can look no farther than Matt Miller, VP of MiMedx Group (Destin, Florida).
In between a host of conference calls and meetings Miller was able to discuss recent news and plans of the neophyte company, which has three subsidiary companies.
Perhaps the strongest news of all is the addition of Parker "Pete" Petit as president/CEO and chairman of the board of directors for MiMedx. Petit formerly served as CEO/chairman of Matria Healthcare (Marietta, Georgia), which was sold to Inverness Medical Innovations (Waltham, Massachusetts) about a year ago.
Matria Healthcare was a former subsidiary of Healthdyne, a company which Petit founded in 1971. Healthdyne became a publicly traded company in 1981.
"He has a proven track record when it comes to raising money and getting a product to the market," Miller told Medical Device Daily.
Raising that funding to get the device to market is going to be paramount and one of the primary focuses for the company and its subsidiaries right now, according to Miller.
The subsidiaries are LeveL Orthpaedics, SpineMedica and MiMedx (all of Destin).
The steps to obtaining those goals have already somewhat been put in place. According to Miller, in 2009 — assuming the company meets its financial challenges — its scientists and engineers will continue to pursue "significant and important results" designed to furnish it with a robust product pipeline.
MiMedx is working to achieve several milestones in 2009:
• SpineMedica expects to initiate design verification performance testing on its cervical artificial disc, which will be used for cervical spinal disc replacement. Satisfactory performance testing data would be used in support of an IDE submission to the FDA.
• SpineMedica hopes to gain regulatory clearance for the Parad s Vaso Shield TM in the US and Europe by mid-year. Upon such approval, this innovative product could then be used by surgeons to isolate critical organs from the growth of scar tissue.
• SpineMedica plans to introduce the Parad s Vaso Shield at the Spine Arthroplasty Society (Aurora, Illinois) meeting in London in April and the American Association of Neurological Surgeons (Rolling Meadows, Illinois) meeting in San Diego in May.
• MiMedx expects to complete the validation of manufacturing, packaging, and sterilization of the first NDGA collagen-based product, the BioBraid. The first use of this product could be in the veterinary market.
• MiMedx expects to submit the BioBraid for FDA 510(k) marketing clearance, intended for augmentation and repair of achilles, patellar, biceps, tibial tendons, and the rotator cuff.
"What we'd like to do is commercialize and get to market as many products as we can and gain a substantial market share," Miller said.
To date the small med-tech firm has seen some success that could lead to robust growth down the line. The most important steps include:
• SpineMedica completed the development of its Parad s Vaso Shield surgical sheet product, culminating in a submission for FDA 510K marketing clearance.
• MiMedx successfully completed the build-out of its manufacturing facility, which is designed to permit the company to operate in accordance with Good Manufacturing Practices (GMP) guidelines, which is important for seeking FDA and CE approval. This facility is now able to continuously spool NDGA-cross linked collagen fibers.
• MiMedx finalized the design and concluded initial testing on its first NDGA cross-linked collagen product, the BioBraid, designed for tendon augmentation and repair.
• LeveL Orthopedics developed and applied for patents on products focused on the fast-growing small bone and joint field for the hand.
Miller said the company has a need for "substantial additional funding" for these product lines in order to continue as a going concern. While the capital markets have changed dramatically over the past several months, MiMedx feels strongly that the leadership of the company, particularly with the addition of Petit as chairman/CEO, has the ability to position the company for its future opportunities.
"What we want to do in the next 24 months is to commercialize as many of our products as possible," Miller said. "We're focused on keeping our head above water. I think it's foolish for a small company out here to put out 5-year plans. The companies that are going to survive are those that can effectively manage their capitalization."