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Sanuwave Health, HyperMed partner for DermaPace diabetic foot ulcer study

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Sanuwave Health (OTC:SNWV) said yesterday it is partnering with HyperMed to sponsor a clinical investigation exploring Sanuwave’s DermaPace system designed for treating diabetic foot ulcers. The joint study will look to quantify the level of increased perfusion and oxygenation during and after treatment with the DermaPace, Suwanee, Ga.-based Sanuwave said. The study will use HyperMed’s Hyperview […]

7 medtech stories we missed this week: July 21, 2017

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From Second Sight’s South Korean market entry to Sanuwave’s Indonesian distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Second Sight enters South Korea market Second Sight announced in a July 5 press release that it has entered the market in South Korea with the implantation […]

Sanuwave Health inks dev deal with eKare for wound care integration

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Sanuwave Health (OTC:SNWV) said today it entered a memorandum of understanding with eKare to develop novel wound care analysis and management solutions which integrates technology from both companies. Through the deal, Sanuwave’s dermaPace wound treatment device will be linked with eKare’s inSight 3D wound imaging and analytics system to produce a comprehensive wound management solution, […]

Sanuwave Health taps Lithomed as Taiwanese ortho distributor

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Sanuwave Health (OTC:SNWV) said today it tapped Lithomed as its orthopedic product distributor in Taiwan. Suwanee, Ga.-based Sanuwave said the selection of Lithomed was the result of an extensive search in the region, and that the contract comes with a minimum order value of $500,000. “Sanuwave has committed to deliver 3-5 new distribution partners in the second […]

Teleflex CEO Smith to step down | Personnel Moves | March 1, 2017

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Teleflex (NYSE:TFX) said this month that CEO Benson Smith will retire from the corner office by the end of this calendar year. Smith will continue to serve as the company’s chairman of the board. Liam Kelly, president & chief operating officer, was tapped to succeed Smith as CEO for the Wayne, Pa.-based company. “I want to […]

Sanuwave files for de novo FDA nod for DermaPace wound care device

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Sanuwave Health (OTC:SNWV) said last Thursday it filed a de novo petition with the FDA as it seeks approval for its DermaPace system designed for treating diabetic foot ulcers. Sanuwave said it expects to hear a response from the FDA within 120 days, and is hopeful that evidence from over 336 patients across 2 trials are enough […]

Sanuwave trial misses efficacy endpoint but shows superiority at 24 weeks

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Sanuwave Health (OTC:SNWV) today released 24-week data from the pivotal trial of its dermaPace, saying it missed its 12-week primary efficacy endpoint but returned a greater reduction in wound size and lowered amounts of subjects with increased wound size compared to the control treatment at 24 weeks. Data came from 2 24-week studies at 39 centers across the […]

Sanuwave Health brings in $1.5m for dermaPACE

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Sanuwave Health (OTC:SNWV) said Monday it closed a $1.5 million round of equity financing to help support the FDA submission of Phase III clinical trial data to support the clearance of its dermaPACE device designed for treating diabetic foot ulcers. The company said it expects to close another round with an additional amount under the […]

BrainScope wrangles up new C-suite | Personnel Moves

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Brainscope today announced a number of new assignments to its executive roster, assigning 4 new picks to its c-suite. The Bethesda, Ma.-based neurotech company picked up Dr. Leslie Prichep as chief scientific officer, Kerstin Schultz as president and COO, Angad Singh as chief technology officer, and promoted Laurie Silver to CFO. “These additions to our leadership team will help […]

Biolase CEO succession continues | Personnel Moves

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Biolase (NSDQ:BIOL) said earlier this month that CEO Jeffery Nugent has resigned from both his position as CEO and the board of directors, effective July 12, to be replaced by Harold Flynn. Irvine, Calif.-based Biolase picked up Flynn, the former president of Zimmer Dental (NYSE:ZMH), in May to replace Nugent, who the company said had stepped in to […]

Sanuwave updates on PMA trial for Dermapace

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Sanuwave Health (OTC:SNWV) said yesterday it met with the FDA to discuss the progress of a pre-market approval trial of its Dermapace diabetic foot ulcer treatment. The 130-patient study completed enrollment in November last year and each patient has completed a full-24-week follow-up, the Alpharetta, Ga.-based company said. Sanuwave said it is completing an audit of the clinical documentation of […]

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