Neuronetics reels in $108m from IPO

Neuronetics (NSDQ:STIM) this week closed its initial public offering, according to a document filed with the SEC.

The Malvern, Penn.-based company said that it offered 6,325,000 shares of its common stock and that underwriters exercised in full their option to buy additional shares, bringing the total proceeds from the IPO to $107.5 million.

Shares began trading on the Nasdaq exchange under the ticker symbol ‘STIM’ last week. The company’s shares closed at $25.50 apiece today, down -1.5%.

Neuronetics’ NeuroStar device uses strong magnetic fields to stimulate areas of the brain associated with mood. The device is designed to treat patients with major depressive disorder who do not respond to medication.

In December of 2008, the NeuroStar device won 510(k) clearance from the FDA as a treatment for adults who previously failed to respond to one medication. But in May 2014, the U.S. regulatory agency expanded the device’s indication to include adults who do not respond to one or more medications.

Approximately 50,000 patients have been treated with the device, according to Neuronetics.

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Intuitive Surgical wins FDA nod for 60mm stapler

Intuitive Surgical (NSDQ:ISRG) said today that the FDA cleared its fully-wristed 60 mm stapler, SureForm 60.

The device is a single-patient-use stapler featuring 120 degrees of fully-wristed articulation, which Intuitive touts as “an industry first.”

Beyond the 60 mm device, Intuitive’s stapling portfolio includes 30 and 45 mm stapler instruments.

The stapler uses Intuitive’s SmartFire software to measure tissue compression before and during staple firing, automatically adjusting to the firing process as staples are formed, the company explained.

Surgeons control Intuitive’s latest stapler via the daVinci console – it’s compatible with the da Vinci Xi and X systems. The SureForm 60 device has general, thoracic, gynecologic, urologic and pediatric indications, according to Intuitive.

“Intuitive continues our minimally invasive innovation with our 60mm stapler, rooted in extensive research and development and an understanding of surgeons’ needs,” Sal Brogna, EVP & COO, said in prepared remarks.

ISRG shares were trading at $487.39 apiece in late afternoon activity today, up +0.4%.

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Siga Technologies touts pivotal data for oral smallpox therapy

Siga Technologies (NSDQ:SIGA) said today that data from a pivotal human safety study and animal efficacy studies of its oral smallpox therapy were published in the New England Journal of Medicine.

Data from the studies support the efficacy and favorable safety profile of Tpoxx, an oral formulation of tecovirimat.

Get the full story at our sister site, Drug Delivery Business News.

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Hologic wins CE Mark for Panther Fusion MRSA assay

Hologic (NSDQ:HOLX) said today that its Panther Fusion MRSA assay won CE Mark clearance in the E.U.

The company’s MRSA assay can detect and differentiate between Staphylococcus aureus and methicillin-resistant Staphylococcus aureus in ESwab nasal samples. The test is the latest in Hologic’s portfolio of Panther Fusion and Aptima assays.

With the company’s Panther Fusion system, laboratories can run up to 32 different assays at the same time. MRSA samples can be loaded directly into the Panther Fusion system and labs can expect the test’s results in 2.4 hours, according to Hologic. The Panther Fusion system enables the lab to process up to 500 assays in an 8-hour period, the company added.

Panther Fusion is available as a standalone system or as a module that can attach to existing Panther systems. The module allows labs to run PCR assays in addition to tests based on transcription-mediated amplification, Hologic said.

“The launch of the Panther Fusion MRSA assay demonstrates our commitment to expanding the portfolio of assays available for Panther Fusion, enabling our European customers to deliver a better service to their clients and ultimately to patients,” João Malagueira, VP of diagnostics for Hologic’s EMEA unit, said in prepared remarks.

“With rising antibiotic resistance in Europe and the threat posed by healthcare-associated infections to public health, our new assay will help customers provide a rapid service to hospitals, so cases of resistance, such as MRSA, are identified and managed quickly and effectively,” Malagueira added.

HOLX shares were trading at $39.72 apiece in mid-morning activity today, up 0.5%.

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Boston Scientific inks $202m deal to buy Cryterion Medical

Boston Scientific (NYSE:BSX) said today that it plans to pay $202 million upfront to acquire Cryterion Medical and its single-shot cryoablation device designed to treat atrial fibrillation.

Adding a cryoballoon platform to its portfolio positions the company as the first to have both cryothermal and radiofrequency balloon-based ablation therapies at its disposal, the medtech giant touted.

Boston Scientific has invested in California-based Cryterion Medical since its beginnings in 2016 and the $202-million pricetag represents the remaining 65% stake.

Single-shot ablation therapies are the fastest growing sub-segment within the $5 billion electrophysiology market, Boston Scientific reported.

Cryterion Medical’s platform leverages cryothermal energy to disrupt the irregular electrical signals that can trigger atrial fibrillation. The company’s device is undergoing clinical investigation in Europe and Cryterion Medical plans to submit for CE Mark clearance in early 2019. The company is also slated to pursue regulatory approval in the U.S., aiming to start enrolling patients in an IDE trial next year.

“Initial clinical study results demonstrate that our system has a promising safety profile as well as acute efficacy,” Keegan Harper, Cryterion Medical’s president & CEO, said in prepared remarks. “We look forward to bringing this advanced cryoablation system to market with the support of Boston Scientific.”

“The acquisition of Cryterion Medical enhances our AF ablation procedure offerings, allowing physicians to select a therapeutic option based on clinical preference and specific patient needs,” Dr. Kenneth Stein, SVP & CMO of Boston Scientific’s rhythm management & global health policy unit, added. “We are committed to providing physicians with a comprehensive suite of therapies that lead the way for clinical advancements and address the needs of the increasing population of patients with AF.”

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Fresenius Medical Care offers $585m in notes

Fresenius Medical Care (NYSE:FMS; ETR:FRE) this week successfully placed notes with an aggregate principal amount of €500 million ($584.9 million).

The notes will mature in 7 years and have an annual coupon of 1.5%, the company noted. Fresenius reported that the issue price is 99.704% and the resulting yield amounts to 1.545%.

“The transaction was very well received by investors and substantially oversubscribed. The proceeds will be used for general corporate purposes, including the refinancing of upcoming maturities,” Fresenius said in a press release.

Last week, the medtech giant inked a $150 million strategic partnership with Humacyte, landing exclusive rights to commercialize Humacyte’s Humacyl bioengineered blood vessel technology.

Research Triangle Park, N.C.-based Humacyte is positioning its Humacyl human acellular vessel as a conduit for hemodialysis in patients with end-stage renal disease who cannot have fistula placement.

According to the terms of the deal, Fresenius Medical will be responsible for the marketing, sales and distribution of Humacyl following appropriate regulatory approval. Fresenius is also slated to make a $150 million equity investment to obtain a 19% fully diluted ownership stake in Humacyte, with the deal expected to close next month.

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Integer closes $600m sale of advanced surgical, ortho lines to MedPlast

Integer (NYSE:ITGR) completed the spinoff of its advanced surgical and orthopedics products lines to MedPlast for $600 million in cash. Announced in May, the deal will double MedPlast’s top line and bolster the balance sheet for Integer, which missed expectations with its first-quarter earnings.

Integer said it will apply the proceeds to reduce debt by about $550 million, which will include redeeming its 9.125% senior notes, paying off the balance of its revolving credit line and prepaying Term B loans. The company expects the divestiture will boost share prices because the lower interest expense from the debt reduction will more than offset the net income being divested, it said in a statement.

The deal does not include Frisco, Texas-based Integer’s portable medical line, the companies said previously. Integer said it will elaborate on the financial impact of the deal in its second-quarter results on Aug. 2.

“We believe this action has already created significant value for Integer shareholders and positions us to even more aggressively execute on our strategy,” said Integer CEO Joe Dziedzic in the statement. “Our operational strategy, comprised of six strategic imperatives focused on customers, costs and culture, is a multi-year roadmap to achieving excellence in everything we do.”

The divestiture leaves Integer a $1.2 billion company with higher margins, increased earnings, greater returns on invested capital, and significantly lower debt leverage, according to Dziedzic. ” We are executing our strategy to drive accelerated long-term growth and realize our vision of enhancing patients’ lives and earning a valuation premium for our shareholders,” he said.

It’s the third buyout in two years for privately held MedPlast, which bought Vention’s medical device manufacturing services division in March 2017 for an undisclosed amount and acquired medical device assembler Coastal Life Technologies three months later. The Tempe, Ariz.-based company has said its sales will near the $1 billion mark after the deal, which will also expand its footprint in Europe.

Integer’s stock closed yesterday at $65.80, up from $40.01 one year ago.

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Catalent expands early-phase development skills with $139m Juniper buyout

Catalent (NYSE:CTLT) said today that it inked a $139 million deal to acquire Juniper Pharmaceuticals (NSDQ:JNPR) and its early-stage product development services.

The company noted that its Juniper acquisition, set at $11.50 per share, will complement Catalent’s formulation development offerings, bioavailability solutions and clinical-scale oral dose manufacturing capabilities.

Get the full story at our sister site, Drug Delivery Business News.

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Ocular Therapeutix resubmits NDA for ocular pain relief implant

Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a new drug application for its Dextenza ocular pain relief implant to the FDA.

The Bedford, Mass.-based company noted that the resubmitted application aims to address manufacturing deficiencies highlighted by the FDA last year when the agency rejected Dextenza for the second time.

Get the full story at our sister site, Drug Delivery Business News.

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Sage Therapeutics’ chief scientist on discovering drugs and taking risks

When Al Robichaud got his start as a medicinal chemist in 1991, he knew that discovering and developing drugs meant shouldering some level of risk.

But around 2011, it became clear that the process for developing brain drugs was too costly and risky for major pharmaceutical companies to justify pursuing, as companies including Novartis (NYSE:NVS), GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY) significantly downsized their neuroscience units.

Robichaud couldn’t shake the feeling that the industry was on the verge of walking away from what is at the very core of drug discovery.

Get the full story at our sister site, Drug Delivery Business News.

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