Tela Bio raises more than $2 million

Tela BioRegenerative surgical implants company Tela Bio has brought in more than $2 million in investments, according to a recent U.S. Securities and Exchange Commission filing.

The Malvern, Pa.–based company had sought to raise a total $3 million, according to the SEC Form D filed Dec. 4.

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

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OrthoPediatrics announces pricing of common stock offering

OrthoPediatricsOrthoPediatrics (NSDQ:KIDS) said today it will price an underwritten follow-on public offering of 1.5 million shares of its common stock at $27 per share.

The company said it plans to use the proceeds of offering to invest in implant and instrument sets for consignment to its customers, fund research and development activities, expand its sales and marketing programs and working capital and general corporate purposes.

The offering is expected to close on or around December 11, 2018, according to a regulatory filing. The Warsaw, Ind. company has also granted the underwriters a 30-day option to purchase up to an additional 225,000 shares of its common stock at the public offering price.

In May, OrthoPediatrics won FDA 510(k) clearance for its Femur pediatric nailing platform. The company’s Femur system is designed to accompany two pediatric-specific nail offerings and is an upgrade to an earlier version of the device. OrthoPediatrics said the clearance of the device is the “next step” in the evolution of its intramedullary nailing franchise.

The company’s shares opened at $27.25 today, and had climbed to $30 by noon Eastern time.

 

 

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What is the future of medtech in 2019?

future of medtech medical device predictions crystal ball

[Image from Unsplash]

A global push to increase medical device industry regulation and the continued blurring of high tech and medtech – those are but some of the predictions that Medical Design & Outsourcing editors are hearing from experts.

Read on to discover some of the top predictions of where the industry is going in 2019.

Next>>

Senior editor Nancy Crotti and assistant editor Danielle Kirsh contributed to this report. 

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Vapotherm touts automated oxygen controller in preemie study

VapothermA recent clinical trial showed that Vapotherm’s (NYSE: VAPO) new IntellO2 module for its Precision Flow system greatly improved the chances of keeping premature babies in the target oxygenation range.

The prospective, multi-center, controlled, order-randomized crossover trial demonstrated that using the IntellO2 module helped clinicians maintain newborns in the physician-prescribed oxygen saturation range 80% of the time, compared with 49 % for manual control alone, the company said in a statement. The study was published in the Archives of Disease in Childhood: Fetal and Neonatal Edition.

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BTG’s bioconvertible IVC filter implanted in Arizona patients

BTGBTG (LSE: BTG) today announced the first successful implantation of its Sentry bioconvertible inferior vena cava (IVC) filter in patients outside of a clinical trial.

The Sentry device won FDA 510(k) clearance in 2017. London-based BTG acquired the device in September through its purchase of Galway, Ireland–based Novate.

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NxThera spinout NxPhase lands $10m for vapor ablation tech

NxPhase MedicalNxPhase Medical – spun out of NxThera when Boston Scientific bought it this year– has raised more than $10 million, according to a recent U.S. Securities and Exchange Commission filing.

Maple Grove, Minn.–based NxPhase is focused on using convective thermal water vapor to treat prostate, kidney, and bladder cancer, according to its LinkedIn page.

Get the full story on our sister site Medical Design & Outsourcing. 

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Medtronic studies use of both heat and cold for cardiac ablation

Medtronic logo updatedMedtronic today said that a St. Louis heart team has treated the first patient in the company’s Terminate AF trial, which is studying the simultaneous use of heat and cold to produce cardiac ablation for atrial fibrillation treatment.

The goal is to determine the safety and efficacy of treating persistent atrial fibrillation in patients undergoing other surgical heart procedures including bypass surgery, heart valve repair or replacement, according to the Medtronic.

During a recent open-heart surgical procedure, a team led by Dr. Ralph Damiano at the Washington University School of Medicine in St. Louis used both the Cardioblate irrigated RF system and the CryoFlex surgical ablation system. The surgical team used both Medtronic devices to make a pattern of lesions in the heart muscle in order to help it return to its normal rhythm.

“The Terminate AF trial provides a unique opportunity to study the combined use of two surgical ablation technologies to treat surgical patients who suffer from AF,” Damiano said in a news release.

“We anticipate the trial will help us uncover important procedural insights and potentially help surgeons and heart teams treat more patients with this widespread disease,” said Damiano, who is the national principal investigator of the Terminate AF trial.

The study will involve up to 15 centers in the U.S. and up to 160 patients. Researchers will assess patients at one, three, six and 12 months; the primary efficacy endpoint is for patients to not have AF after the removal of antiarrhythmic drug therapy (three months post-procedure).

“An indication for the surgical treatment of AF would enable physician training and education and would serve as the basis for ongoing clinical evidence generation,” said John Mack, VP and general manager of Medtronic’s Cardiac Surgery business.

FDA cleared Cardioblate in 2000 and CryoFlex in 2004.

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Monteris Medical scores reimbursement win with Aetna

Monteris MedicalMore epilepsy patients could have access to procedures involving Monteris Medical’s NeuroBlate system after a new coverage update from health insurance giant Aetna.

The coverage update, which Monteris Medical announced today, involves Aetna’s medical policy for laser interstitial thermotherapy (LITT). It provides coverage for Aetna beneficiaries with refractory epilepsy who have met the established medical necessity criteria for a surgical treatment option.

“Our aim is to ensure that physicians can choose the most appropriate surgical approach for their patients. For many epilepsy patients, a minimally-invasive alternative will be the right choice,” Monteris Medical Martin J. Emerson said in a news release.

“By reducing the barriers for epilepsy patients seeking minimally-invasive intervention options, Aetna has empowered more individuals and their families to pursue options that will best meet their needs,” Emerson said.

The NeuroBlate surgical system is minimally invasive and robotic. It uses lasers to ablate brain lesions.

The coverage update from Aetna represents more good news for Monteris Medical after a rocky start to 2018, when FDA labeled a Monteris recall as Class I. The recall involving unexpected heating and damage to the tip of the probe when it interacted with an MRI.

Monteris Medical resolved the heating issue last month when it received FDA clearance for a laser probe with fiber optic controlled cooling to use in the NeuroBlate system. The probe replaced metal thermocouple inside the laser probe, and enabled Monteris to lift MR scan restrictions.

Also last month, Monteris announced that more than 2,000 patients have been treated with the NeuroBlate system since its market release in 2013.

Monteris Medical in June announced the completion of a $26.6 million Series C financing.

 

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Reshape Lifesciences settles with institutional investors for $700K

ReShape LifesciencesJust days after it announced that it had raised $10 million in a registered direct offering, ReShape Lifesciences (NSDQ:RSLS) disclosed in a regulatory filing that it’s paying $350,000 to each of the two institutional investors involved.

The U.S. Securities and Exchange Commission filing, dated yesterday, said the money settles a dispute that arose prior to the closing of the registered direct offering.

The two investors agreed to buy 8 million shares of ReShape common stock as well as warrants to purchase 8 million shares, at a purchase price of $1.25 per share, according to a previous news release. H.C. Wainwright & Co. acted as the exclusive placement agent.

On top of the $10 million raised in the registered direct offering, the weight loss device maker has also brought in $15 million related to an at-the-market facility that commenced in October.

“We are really pleased with the progress we have made in getting our capital structure back to health,” ReShape CEO Dan Gladney said in a news release yesterday.

“We believe that the completion of these recent financings combined with the previous series of financings, the elimination of the series D convertible preferred shares and the reduction of our monthly burn rate from $3.5 million to $1.5 million, position ReShape Lifesciences with a solid runway to execute our strategic plan,” Gladney said.

This isn’t the first time this year that ReShape has run into troubles with a money raise. In August, the company disclosed that it withdrew from an underwriting agreement with H.C. Wainwright & Co. because Nasdaq determined that the offering was not a public offering and therefore could not be completed without shareholder approval.

The company’s stock has been trading under $1 per share in recent days.

ReShape (San Clemente, Calif.) has been developing minimally invasive medical devices to treat obesity and metabolic diseases. Its portfolio includes the ReShape Balloon, ReShape vBloc, and ReShape Vest.

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Zeus: Try our heat shrink products at no cost

ZeusPolymer extrusion and tubing company Zeus seems to be taking a page out of the sales playbook of software companies and direct marketers.

Zeus (Orangeburg, S.C.) is telling medical device companies interested in switching to its peelable heat shrink tubing that they can initially try it out for free.

Get the full story on our sister site Medical Design & Outsourcing. 

 

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