by David Cassak
Consider all of the things that have to go right to successfully develop and launch a new medical device: first...
Given how many start-up companies and their investors have rushed into spine over the past decade or so, one might assume that getting spine surgeons to adopt new technology is relatively easy. - But less than five years after the launch of the first artificial disc was supposed to usher in the era of motion preservation, surgeons are still arguing for the benefits of fusion over disc replacement--underscoring the tension between new devices and traditional therapy options. But one start-up, Vertos Medical Inc., has found a creative way around the adoption issue. Promoting a novel approach to spinal stenosis, Vertos' solution is to focus on the patient, rather than the surgeon, treating stenosis earlier in the continuum of care by reaching out to a new clinical specialty, interventional pain physicians.
by David Cassak
Consider all of the things that have to go right to successfully develop and launch a new medical device: first...
Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
The biotech funding landscape is undergoing a fundamental shift. With traditional VC becoming increasingly cautious and selective, industry executives are exploring new avenues for capital. Conversely, this evolution may ultimately benefit the sector's long-term sustainability.
MoonLake Immunotherapeutics is racing ahead in the biotech space with its innovative nanobody SLK and a transformative $500m non-dilutive financing deal. In this episode, its CEO and CFO discuss the company’s rapid clinical progress, financial strategy and ambitions to reshape inflammatory disease.