Profound Medical (OTCQX:PRFMF; TSXV:PRN) announced that benign prostatic hyperplasia (BPH) treatments utilizing TULSA-PRO are now being successfully conducted in Germany.Read More
Closely held Implandata Ophthalmic Products of Germany has received CE Mark for its EYEMATE system, making it available for commercial use within the EU.Read More
Profound Medical (TSXV:PRN; OTCQX:PRFMF) posted revenue for the first time in the first quarter this year and reported that its TACT clinical trial to support a marketing application to FDA for its TULSA-PRO device is 25% enrolled.Read More
IntelGenx (OTCQX:IGXT; TSX-V:IGX) and RedHill Biopharma (NASDAQ, TASE:RDHL) announced that the Ministry of Health of Luxembourg has granted national marketing authorization for RIZAPORT (5 mg and 10 mg), an oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines.Read More
RepliCel Life Sciences (OTCQB:REPCF; TSXV:RP; FRA:P6P2) reported statistically and clinically significant positive data from an interim analysis of its Phase I study evaluating RCS-01 for the treatment of aging and sun-damaged skin.Read More
Profound Medical (OTCQX:PRFMF; TSXV:PRN) has successfully completed the first sale of a TULSA-PRO system in Finland to the Turku University Hospital, in collaboration with Royal Philips, who is working in partnership with Profound to commercialize the TULSA-PRO system in Europe.Read More
RepliCel Life Sciences (OTCQB:REPCF; TSX-V:RP; FRA:P6P2) has signed agreements with two European firms to get the company's commercial-grade RCI-02 dermal injector prototypes manufactured and tested.Read More
Common shares of 3D Signatures (TSX-V:DXD) have started trading on the OTCQB Venture Market in the U.S. under the symbol, TDSGF, and on the Frankfurt Stock Exchange (FSE) in Germany under the symbol, 3D0.Read More
IntelGenx (OTCQX:IGXT; TSX-V:IGX) and RedHill Biopharma (NASDAQ,:RDHL; TASE:RDHL) have signed an exclusive license agreement with Pharmatronic for the commercialization of Rizaport in South Korea.Read More
Echelon Wealth Partners raised its price target for RepliCel Life Sciences (TSX-V:RP) to $2.15 from $1.50 after the company closed a unit offering that will add about $4.1-million in net cash to its balance sheet. The stock closed at $1.03 on Monday.
“The recapitalization provides funds to drive [RepliCel’s hair follicle-derived] non-bulbar dermal sheath cell platform forward with renewed vigor,” writes analyst Doug Loe, noting that he expects interim six-month data from a Phase 1/2 Achilles tendinosis/RCT-01 study by yearend.Read More
Profound Medical (TSX-V:PRN) has received Frost & Sullivan’s 2016 European Prostate Ablation Systems New Product Innovation Award for its TULSA-PRO system.
TULSA-PRO, which received CE Mark approval in April 2016, combines real-time MRI with transurethral, robotically driven therapeutic ultrasound and closed-loop thermal feedback control designed to provide precise ablation of the prostate, while simultaneously protecting critical surrounding anatomy from potential side effects.Read More
The first patient has been treated in Profound Medical’s (TSX-V:PRN) TACT pivotal trial at Vanderbilt University Medical Center in Nashville, TN.
TACT is a prospective, single-arm pivotal clinical study of 110 patients aimed at further evaluating the safety and efficacy of TULSA-PRO to ablate prostate tissue in patients with localized, organ-confined prostate cancer. Multiple sites in the U.S., Germany, Netherlands, Spain and Canada will participate in the trial.Read More
Merck KGaA of Germany (XETRA:MRK.DE) has received approval from the Japanese Ministry of Health, Labour and Welfare for Juniper Pharmaceuticals’ (NASDAQ:JNP) OneCrinone 90 mg (progesterone) for the indication of luteal phase supplementation in assisted reproductive treatment.
“This approval further expands the global Crinone progesterone gel franchise into the world’s’ third largest pharmaceutical market, giving women and couples struggling with infertility in Japan a new, patient-friendly therapeutic option for luteal phase support,” Frank Condella, CEO of Juniper, said in a statement. “We look forward to supporting the launch of OneCrinone in Japan later this year.”Read More
Rodman & Renshaw has initiated coverage of Presbia PLC (NASDAQ:LENS) with the “buy” rating and 18-month price target of $14. The stock closed at $3.90 on Tuesday.
Presbia has a novel corneal inlay product, the Flexivue Microlens, aimed at treating presbyopia, or nearsightedness.Read More
Profound Medical (TSX-V:PRN) has received CE Mark approval for the commercial sale of Tulsa-Pro.
Profound’s novel technology combines real-time magnetic resonance imaging with transurethral robotically-driven ultrasound and closed-loop thermal feedback control to provide a highly precise treatment tailored to patient-specific anatomy and pathology.Read More