Why the FDA Commissioner Pushed To Shorten Medical Device Approval Process
Palm Beach, FL – March 19, 2019 – We all know the FDA is the arm of the U.S. government that, among other things, controls and oversees the approval process for medical device products and technologies are used in the diagnosis, prevention and treatment of diseases. It is estimated that presently bringing a device to market takes an average of 3 to 7 years. Last November, it appeared that the Commissioner of the FDA intended to drastically shorten the approval process. In a recent article published on CNBC.com, Commissioner Scott Gottlieb said: “We plan to overhaul the 510(k) clearance process for medical devices… and push the medical device market toward new technology. The FDA is overhauling the most common way medical device manufacturers bring their products to market in an attempt to advance new technologies.” Gottlieb continued “What we want to do is constantly push the market toward incorporating better technology and better capabilities by advancing the predicates and always looking forward so the … predicates the device companies are using as the basis of their approvals are constantly incorporating newer and better technology to make the devices better and safer.” Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), Medtronic plc (NYSE: MDT), PDL BioPharma, Inc. (NASDAQ: PDLI), Innovate Biopharmaceuticals, Inc. (NASDAQ: INNT), Puma Biotechnology, Inc. (NASDAQ: PBYI).
“Last year, the FDA cleared 3,173 devices through this system, or 82 percent of the total devices cleared or approved, Gottlieb and Shuren said in their statement. Nearly 20 percent of products cleared through the 510(k) pathway are based on a predicate device that’s more than 10 years old, they said. The FDA plans to finalize its guidance on establishing an alternative accelerated pathway early next year.”
Soliton, Inc. (NASDAQ: SOLY) BREAKING NEWS: Soliton, a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (“MD Anderson”), completed the human trials of its proprietary Rapid Acoustic Pulse (RAP) Device to support the Company’s FDA 510(k) submission. The Company conducted three rounds of human trials to study the use of the RAP device to accelerate tattoo fading.
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“The human trials provided evidence of the potential for the RAP technology to accelerate tattoo fading,” said Dr. Chris Capelli, Soliton’s President and CEO. “The combination treatment of the RAP device and a laser outperformed a laser alone, showing an average of 80% fading after only two visits vs 44% fading for the laser alone. After 3 Soliton Multi-Pass treatments, 100% of the treated tattoos had a ‘Complete’ (76-100% faded) response; in comparison, only 17% of the tattoos treated with the Laser Only had a ‘Complete’ response.” Read this and more news for SOLY at: https://financialnewsmedia.com/news-soly/
Other recent developments in the healthcare, biotech industries:
Medtronic plc (NYSE: MDT) recently announced results from the landmark Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), which demonstrated the TYRX(TM) Absorbable Antibacterial Envelope (TYRX envelope) reduced the risk of major infection by 40 percent, and pocket infection by 61 percent, in patients with cardiac implantable electronic devices (CIEDs), compared to standard-of-care pre-operative antibiotics. The trial results were presented today in a late-breaking session at the American College of Cardiology`s 68th Annual Scientific Sessions (ACC.19), and published simultaneously in The New England Journal of Medicine.
“CIED infections are associated with significant morbidity, mortality and cost. Until now, in addition to adhering to strict surgical techniques, only one intervention, pre-operative antibiotics, has been shown to significantly reduce infections,” said Khaldoun Tarakji , M.D., M.P.H., associate section head of cardiac electrophysiology at Cleveland Clinic, principal investigator of the trial, and a paid consultant to Medtronic.
PDL BioPharma, Inc. (NASDAQ: PDLI) On March 14, the company, reported its financial results for the three and 12 months ended December 31, 2018. Financial Highlights:
- Total revenues of $45.1 million for the 2018 fourth quarter and $198.1 million for the full year.
- GAAP net income of $16.3 million or $0.11 per diluted share for the 2018 fourth quarter and a GAAP net loss of $68.9 million or $0.47 per share for the full year. The full year loss was a result of a non-cash accounting charge related to the impairment of an intangible asset from Noden Pharma DAC, due to the expected launch of a generic version of aliskiren in the United States.
- Non-GAAP net income attributable to PDL’s shareholders of $15.1 millionand $56.7 million for the 2018 fourth quarter and full year, respectively. A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 at the end of this news release.
- Cash and cash equivalents of $394.6 million as of December 31, 2018.
- Repurchased 8.7 million shares of common stock in the open market during the fourth quarter of 2018 at an average price of $2.94 per share, or $25.5 million.
Innovate Biopharmaceuticals, Inc. (NASDAQ: INNT) a clinical stage biotechnology company focused on developing novel autoimmune and inflammation therapeutics, recently announced that on March 17, 2019, it entered into an agreement (the “Agreement”) with SDS Capital Partners II LLC and certain other accredited investors (together, the “Purchasers”) providing for the sale by the Company at a purchase price of $2.33 per share as further described below of up to 4,291,845 shares (the “Shares”) of its common stock (the “Common Stock”), up to 2,575,107 five-year term warrants with an exercise price as further described below at a premium to the purchase price and up to 4,291,845 12-month term warrants at an exercise price of $4.00 (total of up to 6,866,952 shares of Common Stock).
The Company intends to use the net proceeds from this offering to fund initiation of the first Phase 3 clinical trial of its lead program for celiac disease, INN-202, and for working capital and general corporate purposes.
Puma Biotechnology, Inc. (NASDAQ: PBYI) a biopharmaceutical company, recently announced that updated results from the cervical cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the efficacy of neratinib in HER2-mutated cancers, were reported at the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting in Honolulu, Hawaii. “Neratinib in patients with HER2-mutant, metastatic cervical cancer: findings from the phase II SUMMIT ‘basket’ trial,” was presented during the Scientific Plenary Session by Anishka D’Souza, M.D., Assistant Professor of Clinical Medicine, Keck School of Medicine of University of Southern California (USC). SGO selected this abstract as the recipient of the 2019 SGO Presidential Award. Slides from the presentation are available on the Puma Biotechnology website.
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