Delcath Systems Inc.’s phase III FOCUS trial of its Hepzato Kit for metastatic hepatic dominant ocular melanoma (mOM) posted positive results for this challenging and aggressive cancer. Nearly a third of patients responded to the therapy – more than three times the rate seen in those receiving the best available choice – and just under 7% had a complete response. The treatment, known as Chemosat in Europe, isolates the liver for treatment then purifies the blood exiting the liver before it returns to circulation to reduce systemic effects.
Wave Neuroscience Inc.’s study of the use of electromagnetic stimulation to treat post-traumatic stress disorder (PTSD) entered its second phase, building on the positive outcomes seen in the phase I collaboration with the U.S. military. Texas A&M University Health Science Center is directing the trial, which will expand the study to civilians.
The FDA granted 510(k) clearance to Metame Health Inc.’s Regulora, the company’s prescription digital therapeutic (PDT) for abdominal pain associated with irritable bowel syndrome (IBS). Regulora provides gut-directed hypnotherapy in a smartphone app that is designed to help patients better manage their symptoms and address miscommunication between the brain and gut that contributes to sensations of pain.
Virtual Incision Corp. raised $46 million in a series C funding round to support commercialization of its miniaturized in vivo robotic assistant (MIRA) for laparoscopic surgery. The first member of the company’s family of mini-robots in development targets colon surgery. Others in the pipeline will address hernia repair, gallbladder removal, sleeve gastrectomy, hysterectomy and other surgeries with specialized ranges of motion and tools.
The FDA cleared Hyperfine Research Inc.’s advanced image reconstruction technology using deep learning for its portable magnetic resonance imaging device, Swoop. The bedside MRI unit’s artificial intelligence application received clearance in January and is used with deep learning to improve image quality and diagnostic value. Hyperfine and Liminal Sciences Inc., which share a founder in serial entrepreneur Jonathan Rothberg, are both combining with special purpose acquisition company Healthcor Catalio Acquisition Corp. to go public in a deal valued at $580 million. The companies reported on Nov. 29 that the Securities and Exchange Commission declared the registration statement on form S-4 for the combination to be effective and the SPAC’s shareholders will vote on the transaction on Dec. 21.
Sword Health Technologies Inc. slipped another $189 million into its coffers with an oversubscribed $163 million series D fundraising round that spilled into an additional $26 million secondary transaction. The enthusiasm for the round points to the keen interest in digital delivery of musculoskeletal (MSK) physical therapy, which has driven Sword and competitor Hinge Health Inc. both into rarified unicorn territory with valuations of $2 billion and $6.2 billion, respectively.
The FDA gave Pear Therapeutics Inc. a second breakthrough device designation with the company’s Reset-A prescription digital therapeutic (PDT) for alcohol use disorder getting the regulatory agency’s speed pass. The news comes a week out from the vote of stockholders of blank-check company Thimble Point Acquisition Corp. Inc. on a combination with Pear that will take the digital therapeutic company public.
Stryker Corp.’s analyst day provided comfort to those concerned about the company’s ability to return to its strong pre-pandemic revenue and earnings growth after its lower than expected third-quarter earnings results. Management offered positive reports of fourth-quarter trends and a long-term strategy unfolding according to plan.
Sense Biodetection Ltd. closed a $65 million series B investment round on a high note with an additional $15 million pouring in from previous investors. The Abingdon, England-based company raised $50 million in a first tranche of the round in April. Koch Disruptive Technologies LLC, a subsidiary of Koch Industries Inc., led both parts of the round.
Aquyre Biosciences Inc., formerly known as Lltech, raised $19,945,534 in a series A2 preferred stock financing round to fund commercialization of its Celtivity system for on-site adequacy assessments of tissue biopsies. Ceros Financial Services acted as placement agent for more than $17.14 million of the funds raised in this round as part of its recently announced commitment to raise $100 million in the next 12 months for investment in early-stage medical technology and medical device companies.
