Two companies are ringing in the new year with much-needed product approvals. After a disappointing 2017 Sanuwave can look forward to a much better year after its diabetic foot ulcer technology was approved in the US, and Xcision Medical Systems also got US clearance for its only product, a breast radiotherapy system.
Less festive joy was felt by Zimmer Biomet as its protein therapy for osteoarthritis of the knee, nStride, missed the endpoint in a phase II trial. The group plans to press ahead with US approval efforts nevertheless.
The first device intended to treat diabetic foot ulcers using shock waves has been approved in the US, and the clearance is a godsend to Sanuwave. The system is called Dermapace, and uses pulses of energy similar to sound waves to stimulate the ulcer mechanically to promote healing.
In trials, patients given one to seven Dermapace treatments had a 44% wound closure rate at 24 weeks, compared with a 30% rate for those given a sham treatment. The device was approved via the de novo 510(k) route, and ought to be launched in the first half of the year.
Analysts from Zacks Investment Research model 2019 sales of the device in the US at $16.5m, which would be a huge uptick for a company that has had a dismal 2017. Revenues for the nine months ended September 30, 2017 were just $422,199, down 42% from a year earlier. The company said this was due to lower sales of new Orthopace devices and applicators and lower applicator refurbishments in Europe and Asia Pacific.
Anika Therapeutics is able to bring the latest in its range of hyaluronic acid-based bone grafts to the US market after the FDA granted 510(k) clearance. The graft is indicated for filling bone voids or defects in extremities and the pelvis that are not intrinsic to the stability of the bone, and which result from injury or were created during surgery. The filler is injected, hardens at body temperature, and is then resorbed and replaced by new bone during the healing process.
Anika estimates the market for treating tibial plateau fractures, stress fractures around joints and decompression of necrotised bone to be worth around $300m.
Glaukos has filed for US premarket approval of a follow-up to its iStent glaucoma therapy, and this one is injectable. iStent Inject comprises two heparin-coated titanium stents pre-loaded into an injector. The stents are implanted at two sites in the trabecular meshwork via a single injection site in the cornea; after placement they provide routes for the aqueous humour to drain away, relieving intraocular pressure. Glaukos is seeking approval for mild to moderate open-angle glaucoma in patients undergoing cataract surgery, and iStent Inject is designed to be placed during the cataract procedure itself, limiting trauma.
In its pivotal trial the device met its primary effectiveness endpoint, allowing a reduction of at least 20% in intraocular pressure from baseline at 24 months, compared with cataract surgery alone. Full data from the trial ought to emerge in the first half of 2018. iStent Inject is the first of five new products Glaukos plans to bring to market in the next five years. Another, the iStent SA, intended for a different form of glaucoma, had its pivotal US study greenlit by the FDA last week.
An autologous cell therapy for knee osteoarthritis developed by Zimmer Biomet has narrowly failed in a phase II trial. The nStride autologous protein solutions kit is used to extract anti-inflammatory cytokines and growth factors from a patient’s blood, after which they are injected into the knee. In the randomised Progress II study the 31 patients who received an injection of nStride APS had a 65% improvement in the WOMAC pain score, which assesses pain, stiffness and physical function. The 15 patients in the control group, who were injected with saline, had a 41% improvement.
The primary endpoint per the Clinicaltrials.gov record, though, was improvement in pain scores on the visual analogue scale. This was met by 49% of those in the treatment arm compared with 13% of the control group, but with a p value of 0.06 this did not meet significance.
Zimmer Biomet called the results “positive” and said they laid the groundwork for regulatory efforts in the US, and would also enable accelerated commercial adoption in Europe and Japan, where the kit is already approved.
The US FDA has granted marketing authorisation for a new noninvasive stereotactic radiotherapy system intended for treating breast cancer. Xcision Medical Systems’ GammaPod is designed to allow greater accuracy, directing radiation from 36 rotating cobalt-60 sources to a specific area of the breast, which is immobilised using a vacuum cup to minimise damage to adjacent healthy tissue. GammaPod has not been shown to be as effective as whole-breast radiotherapy, and thus will likely be used for less severe cases.
The device was granted 510(k) clearance for use in conjunction with breast-conserving surgery. It is Xcision Medical Systems’ only product, and the company is pushing the idea that its use can reduce costs. Xcision says the device can deliver “a full course of breast cancer radiotherapy in one to five days”, thus freeing up capacity on the more traditional linear accelerators.