Two Frederick, Maryland MedTech Companies Receive FDA 510K Approvals
August 13, 2019
Frederick County, Maryland continues to be a vibrant hub for growing bioscience organizations. With its robust life science support ecosystem and proximity to key government research entities the region continues to produce and nurture exciting biotech companies across a wide range of fields, including a host of notable medical technology (MedTech) companies finding their stride.
Following on the heels of our look at hot Frederick bioscience startups we turn our attention to a two Frederick County, Maryland MedTech companies that recently received FDA approvals for their MedTech devices. Akonni Biosystems, which received FDA 510K approval in June 2019, and the BioElectronics Corporation, which received FDA 510K approval in July 2019, are both Frederick-based MedTech companies to watch.
Akonni Biosystems, founded in 2003, is a molecular diagnostics (MDx) that develops, manufactures and markets integrated molecular diagnostic systems. The company’s mission is to improve the health status of millions of people across the globe by delivering MDx tools that empower rapid, affordable and accurate diagnosis. The organization is focused on developing scalable and flexible diagnostic platforms that enable “…multiplexed pattern recognition of genetic, protein, metabolite or small molecule markers associated with the host or pathogen.”
In June 2019, Akonni Biosystems received U.S. Food and Drug Administration (FDA) approval for its TruDiagnosis® System, signalling the company’s official entry into the $8B molecular diagnostics market. TruDiagnosis is a unique, in vitro diagnostic system based on proprietary gel-drop microarray technology and is part of the company’s core product line, which also includes TruTip® sample prep kits. Being a compact, point-of-service device, TrueDiagnosis helps physicians administer the correct dose levels of CoumadinⓇ. The FDA-approved assay is a non-invasive saliva test that identifies genetic signatures tied to a patient’s metabolization of Coumadin, which will help doctors increase the safety and efficacy of Coumadin dosage levels.
The 510K FDA approval of its TruDiagnosis product, which includes the company’s TruDx® 2000 Imager and the TruArray® consumable test kit, marks the achievement of the first of three key strategic goals for the organization. Now that the diagnostic device is approved, Akonni Biosystems’ next step is to expand the assay diagnostics menu via internal and external assay content development. The final step is to scale its manufacturing to reduce unit costs.
In the company’s press release announcing FDA approval of its TruDiagnosis System, CEO and Founder Charles Daitch, PhD, stated, “The molecular diagnostic industry has been burned by high-end research technologies being force fitted into the quality-stringent, price-sensitive world of clinical diagnostics. Companies have had to charge too much for over-engineered, complex test cartridges. It’s a broken business model for the healthcare industry and Akonni’s goal is to fix this. Many companies have had to penetrate and seed the market by giving away or subsidizing their high-cost consumables resulting in an artificially inflated installed base and a protracted path to profitability. Akonni will expand into the market and reach profitability faster as a result of our technology advancements built into the TruDiagnosis® System.”
Akonni operates out of a 20,000 square foot facility in Frederick and employs approximately 36 people. The company has raised nearly $19 million in funding since it launched and its core technology is based on its proprietary 3D “gel drop” microarrays. Its exclusively-licensed intellectual property portfolio includes 28 issued patents and 90 peer-reviewed publications.
The BioElectronics Corporation, a publicly-traded company (BIEL) founded in 2000 and headquartered in Frederick, is a leader in non-invasive electroceuticals. Led by Founder, President and CEO Andrew J. Whelan, the company develops safe and effective pain management technologies that offer an alternative to opioid-based pain treatments. The company is the maker of an industry leading family of disposable, drug-free, pain therapy devices, including ActiPatch® Therapy, an over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Devices for chronic and post-operative wound care; and the Allay® Menstrual Pain Therapy.
In July 2019, the company received FDA market clearance for its RecoveryRx® medical device for the treatment of postoperative pain. RecoveryRx is now an alternative to opioid focused postoperative pain treatments, which can have limited effectiveness in some patients and include the risk of longer term addiction. In general, according to the company, only 50% of patients report that postoperative pain regiments provide them with satisfactory pain relief. Physicians are increasingly seeking alternatives to opioid-driven pain management. RecoveryRX is now a safe, drug-free and more effective pain management alternative for these physicians and one that could potentially become the standard of pain management care in the near future.
With more than 15 million Americans who experience postoperative pain each year, and approximately 7 million patients that require chronic wound treatments, the BioElectronics Corporation has a tremendous untapped market opportunity with the recent approval of its RecoveryRx medical device.
Akonni Biosystems and the BioElectronics Corporation are just the latest examples of thriving companies that call Frederick, a dynamic bioscience hub with numerous startups, growth-stage organizations, well-established industry anchor companies and government research agencies, home.