Staff Writer

Amphora Medical Inc. closed a series B financing round for $35.5 million, led by Longitude Capital and Boston Scientific Corp. The Minneapolis, Minn.-based company will apply the funding to a trial for its Selective Bladder Denervation System among women with overactive bladder (OAB).

HBM Healthcare Investments, F-Prime Capital Partners and Baird Capital participated in the funding. A July 2015 series A financing amounted to $12.8 million, led by Baird Capital and Michael Liang. The company will consider a series C financing to aid in commercialization, Tom Ressemann, president and CEO, shared with BioWorld MedTech. advance our minimally invasive Selective Bladder Denervation System as a treatment for OAB," said Ressemann. "Upon the completion of two ongoing feasibility studies, we expect to initiate the pivotal, randomized, sham-controlled, selective bladder denervation clinical trial in women who are refractory to medical therapy in 2018." Study design and size for the pivotal research "will be determined following the final analysis of our feasibility trial data later this year," said Ressemann.

Amphora's current feasibility studies, now in follow-up phase, investigated the Selective Bladder Denervation System as an option for women with OAB. "Results to date have demonstrated the potential to restore normal bladder function and provide lasting symptom improvement without side effects or the need for an implant," said Ressemann.

One of the company's trials, a prospective, multinational, multicenter, single arm registry study called cystoscopic ablation via RF energy clinical trial (CARETI), NCT02398578, was a "phase I/II study to assess the safety and performance of the Amphora OAB system for treatment of urgency and frequency with or without urge incontinence caused by an overactive bladder" among patients at a site in Belgium and a site in Canada. Another two phase multicenter planned study, cystoscopic ablation via RF energy clinical trial (CARET 2), NCT02480829, evaluated patients with OAB who are not responding to or unable to tolerate treatment from sites in Poughkeepsie, N.Y., and Sioux Falls, S.D.

Planning for the future

After completion of research, including an upcoming pivotal study, the company plans a commercial launch. They will also consider creating a device for OAB in other populations. "Following the clinical trial, successful CE mark and U.S. clearance, we will launch the product in the U.S. and outside the U.S. for the treatment of women with OAB," said Ressemann. "The company intends to develop a product for the treatment of male OAB."

Amphora's device uses a cystoscope to travel the urethra into the bladder for treatment. The device aims to improve OAB by treating nerves within the bladder with a fulguration procedure, or applying a high-frequency electric current to create heat and impact areas where nerves are over-stimulated. The process is intended to reduce nerve signals so that normal function of the bladder can resume. Due to the targeted nature of the procedure, healthy nerves are unaffected, according to the company, and can aid in later normal bladder functioning.

OAB symptoms

Patients with OAB often feel a sudden and urgent need to urinate, and may or may not experience urinary incontinence. "Today, many OAB patients have few options for managing their symptoms, which can be debilitating," said Marc Galletti, managing director, Longitude Capital. "Amphora's Selective Bladder Denervation system has demonstrated the potential to restore normal bladder function and provide lasting symptom improvement in ongoing feasibility studies, and we believe this proprietary technology has the potential to be a fundamental advancement in the treatment of OAB."

As part of the funding, investors will join the company's board of directors, including Marc Galletti of Longitude Capital and Thomas Thaler, of HBM Healthcare Investments. Ketan Patel from F-Prime and Nicole Walker of Baird already serve on the board. Chris Owens, president and CEO of Gynesonics, will step in as independent director. Aquilo Partners were financial advisors on the series funding.

Device marketplace

Various devices are on the market to treat patients with OAB, with greatly varied approaches to the treatment of the disease from barriers to nerve modulation. An Agency for Healthcare Research and Quality comparative analysis of 15 studies suggested 15.1 percent of women in the U.S. report OAB, and 11 percent of men report OAB and urinary urgency.

OAB can be treated with physical barrier-type devices on the market. For instance, a pessary device is made up of a small plastic or silicone ring inserted in the vagina to hold the bladder in place and prevent leakage. Alternatively, a urethral occlusive device uses a tube structure that is inserted into the urethra and inflated to bock urine. The single-use disposable device is removed before going to the bathroom.

Dublin-based Medtronic plc markets two devices for treatment of OAB and incontinence. Its Nuro system emits electrical impulses to the tibial nerve to lessen urgency symptoms. A needle is placed under the skin and percutaneous tibial neuromodulation applied to decrease OAB and urinary incontinence. The company's Interstim II also emits an electrical impulse to treat OAB, however, this device targets the sacral nerve to reset bladder and brain signaling.

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