Millions of patients with fibromyalgia have battled widespread pain with few effective treatment options for decades. The U.S. FDA has offered reason for hope and better health with four recent decisions. On Oct. 4, Solon, Ohio-based Multi Radiance Medical Inc. (MRM) received clearance for its Fibrolux therapy laser for the condition, following Neurometrix Inc.’s de novo authorization for its transcutaneous electrical nerve stimulation device, Quell, in May. Remedee Labs SA received breakthrough device designation (BDD) for its endorphin stimulation system in May and Swing Therapeutics Inc. was granted BDD for its digital therapy in Aug. 2021.
Vergent Bioscience Inc. raised $21.5 million in a series B financing round to advance development of VGT-309, its targeted fluorescent imaging agent that illuminates tumors during open, minimally invasive and robotic-assisted surgeries. The company plans to use the funds to support a phase II trial at the University of Pennsylvania that focuses on lung cancer and a multicenter study that will examine the agent’s use in other indications.
The American Academy of Ophthalmology (AAO) annual meeting in Chicago Sept. 30 to Oct. 3 covered the waterfront in the ophthalmic market, with positive signs for continued or improving health as supply kinks work out. Hurricane Ian’s impact on the other side of the country was also a topic, as Florida accounts for a disproportionate percentage of cataract surgeries, which may be delayed as a result of the destruction in the state. We provide some highlights from the conference, analysts’ meetings with company executives and some timely new developments in the sector.
Cionic Inc. doubled its funding to date with a $12.5 million series A round led by Bluerun Ventures. The cash infusion will support the manufacturing and delivery of the company’s Neural Sleeve, development of additional products on its human augmentation platform and expansion of the team. The Neural Sleeve received FDA clearance in February and is designed to help individuals with impairments caused by multiple sclerosis, stroke, cerebral palsy and other diseases retain or regain mobility.
Delphinus Medical Technologies Inc. raised $30.4 million in a series D fundraising round to support worldwide commercialization of its Softvue 3D whole breast ultrasound tomography system. Both new and existing investors kicked in funds including Arboretum Ventures, Beringea, North Coast Technology Investors, Venture Investors, Hopen Life Science Ventures and Waycross Ventures.
Otolith Sound Inc. closed a $20 million series A financing round led by Morningside Ventures for its treatment for chronic vertigo. The latest funding follows a $3.3 million seed financing round and breakthrough device designation in June 2021. The funding will be used to support ongoing clinical programs and its anticipated FDA approval of its noninvasive wearable device Vestibular System Masking (nVSM) technology.
Following on a trifecta of regulatory wins, Optellum Ltd. raised $14 million in a series A funding round to commercialize its artificial intelligence (AI)-enabled lung cancer diagnostic platform. Optellum’s Virtual Nodule Clinic, which helps physicians identify and monitor patients at-risk of lung cancer, has received U.S. FDA clearance, CE-MDR in the European Union and UKCA in the U.K.
A new technique may allow reduction of intraocular pressure (IOP) associated with glaucoma without opening the anterior eye chamber, eliminating much of the risk associated with current glaucoma procedures. The cilio-scleral inter-position device (CID) facilitates outflow without creating an artificial egress using a thin one-piece implant.
Colorectal cancer (CRC) is expected to increase steadily through the decade to reach more than 2.2 million cases and 1.1 million deaths by 2030 as two concurrent trends tick up—an aging population, that typically has higher rates of the disease, and an alarming increase in cases in younger people. Iterative Scopes Inc. hopes to help gastroenterologists find precancerous lesions before they progress with its Skout device, which received U.S. FDA 510(k) clearance this week.
Aggressive prostate cancer disproportionately affects—and kills—African American men, but identifying which men are at highest-risk has proved challenging, particularly in younger patients. Veracyte Inc.’s Decipher prostate genomic classifier could help identify these men with early, localized prostate cancer at the greatest risk of aggressive disease, a new study published in the Journal of the National Cancer Institute found.
