Pavmed plans safety study for CarpX following FDA meeting

Pavmed updated logoAfter a meeting with the FDA, Pavmed (NSDQ:PAVM) said that the agency wants to see more clinical testing for the CarpX device before it can make a decision on whether or not to approve the product.

In August last year, the FDA group reviewing Pavmed’s 510(k) application for CarpX requested that the company resubmit the application because the group hadn’t reached a consensus within the designated review period.

The hangup, according to an SEC filing, is that the group is “focused on protection of important structures during the procedure. [The FDA] recommended clinical testing to definitively document procedural safety in humans and provided initial guidance on parameters for this testing.”

The FDA reportedly told Pavmed that a well-designed study outside of the U.S. would be sufficient to prove that CarpX, a minimally-invasive device designed to treat carpal tunnel syndrome, is safe.

The company also announced that it expects to submit CarpX for CE Mark clearance in the European Union by the end of this quarter.

“I am very pleased with how this week’s pre-submission meeting and follow-up interactions with the FDA have gone,” chairman & CEO Dr. Lishan Aklog said in prepared remarks. “The goal of the pre-submission process is to receive clear and definitive guidance on what the company needs to do to demonstrate substantial equivalence. I am grateful that the FDA personnel showed up in force, despite the government shutdown, and engaged in a substantive conversation during which we were able to secure that guidance.”

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Pavmed raises $7m in private placement

PAVmedPavmed (NSDQ:PAVM) said this week that it inked a deal to sell a senior secured convertible note of $7.8 million to an institutional investor.

The note was sold with an issue discount of $725,000, for gross proceeds to Pavmed of $7 million. Maxim Group, which acted as the placement agent for the transaction, received a 6.5% fee, according to a report filed with the SEC.

The company said that after it consummated the sale of its convertible note, Pavmed repaid the outstanding principal balance and all accrued interest on a senior secured note held by an existing lender. Pavmed dealt a cash payment of $5 million to Scopia Holdings and issued 600,000 shares of common stock.

Earlier this year, the FDA group reviewing the 510(k) application for Pavmed’s CarpX device said it wanted the company to resubmit its application.

The FDA told the company that it had not reached a consensus within the review period set by the agency’s rules. To extend the review process, the FDA recommended that Pavmed resubmit the application. In a filing with the SEC, Pavmed said it resubmitted the application in August.

The company’s minimally-invasive CarpX device is designed to treat carpal tunnel syndrome. The device allows physicians to relieve compression of a patient’s median nerve without the use of an incision.

The ultrasound-guided system features a balloon catheter with bipolar radio-frequency cutting electrodes, according to Pavmed. Once the device is activated, it creates a space to protect the nerve from the cutting electrode and decompresses the nerve by dividing the transverse carpal ligament.

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PavMed subsidiary Lucid Dx inks licensing deal with Case Western Univ.

Pavmed (NSDQ:PAVM) subsidiary Lucid Diagnostics said today it finalized a licensing agreement with Case Western Reserve University to commercialize its EsoCheck non-invasive cell sampling device and DNA biomarker test.

The New York-based company said that the EsoCheck device has been shown to effectively and accurately detect Barrett’s Esophagus, which is a precursor to the most common and lethal forms of esophageal cancer caused by Gastroesophageal Reflux Disease.

The EsoCheck test is composed of a pill-sized capsule with a small inflatable balloon attached to a thin catheter. The patient swallows the capsule, which swabs the target area for a sample of cells as it is withdrawn, the company said.

Collected samples are then tested for biomarkers that have been shown to be accurate for detecting Barrett’s Esophagus.

As part of the licensing agreement, PavMed’s Lucid Diagnostics will own the exclusive worldwide right to develop both the device and biomarker test and the associated intellectual property.

“EsoCheck is a revolutionary technology that we believe will save many lives through the early detection of pre-cancerous conditions of the esophagus including Barrett’s Esophagus. We are proud to have been selected to be the exclusive commercial partner of Case Western Reserve University in this important endeavor. Based on the dramatic results of the recently published multicenter clinical study, we believe widespread EsoCheck screening has the potential to have as great an impact on esophageal cancer as widespread Pap screening has had in preventing cervical cancer, targeting an estimated immediately addressable domestic market of several billion dollars,” PavMed chair & CEO Dr. Lishan Aklog said in a press release.

PavMed said that it has launched a multicenter National Institutes of Health study of the EsoCheck, and that it is enrolling patients at Case Western Reserve University Hospital and other healthcare facilities.

“Our multicenter NIH study aims to establish the clinical evidence for EsoCheck’s widespread use as a screening test to detect Barrett’s Esophagus, eventually targeting the estimated 50 million Americans with and without heartburn who are at risk. The EsoCheck device is already being manufactured for human use in clinical trials and the EsoCheck DNA biomarker test is already being performed at a reference laboratory, which expects to receive CLIA certification later this year. As such, we will be able to aggressively pursue EsoCheck commercialization by seeking U.S. Food and Drug Administration (FDA) 510(k) clearance of the cell sampling device and a Laboratory Developed Test designation of the DNA biomarker test. We are targeting the first quarter of 2019 for the launch of the first commercial product in the U.S.,” principal investigator and EsoCheck co-inventor Dr. Amitabh Chak of the Case Western University School of Medicine said in a prepared statement.

Earlier this month, PavMed said that it filed a preliminary prospectus with the SEC for an offering of the rights to buy a new unit in exchange for each share of outstanding common stock.

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Pavmed registers for $20m rights offering

Pavmed (NSDQ:PAVM) said today that it filed a preliminary prospectus with the SEC for an offering of the rights to buy a new unit in exchange for each share of outstanding common stock.

The medical device company plans to offer the rights to purchase up to 9 million units at $2.25 apiece on May 21, valuing the offering at $20.3 million.

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

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Pavmed extends Series W warrant exchange offer through April

Pavmed Inc. (NSDQ:PAVM) said last week it plans to extend its previously announced offering to exchange two Series W warrants for a single Series Z warrant.

The offering from the New York-based company is now extended through to April 2, having previously been set to close today at midnight, according to a press release.

Read the whole story on our sister site, Drug Delivery Business

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Pavmed prices $4.3m offering

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PAVmedPavmed (NSDQ:PAVM) today priced an underwritten public offering of 2,415,278 shares of its common stock at $1.80 per share.

The New York City-based company said it would grant the offering’s underwriters a 45-day option to buy up to 362,292 additional shares of common stock to cover over-allotments.

Pavmed expects to bring in $3.9 million in net proceeds from the offering after discounts and commissions, which it plans to use for working capital and other general corporate purposes.

Yesterday, Pavmed registered for a nearly $90 million offering, saying it plans to float the rights to buy up to 14.6 million units.

The company said it would issue a single unit for each share of common stock. Each unit is slated to include one common share and a six-year Series Z warrant worth $2.25 per share, redeemable at $3 apiece.

Pavmed plans to use the funds it raises from the offering to support its R&D efforts and the development of its current pipeline, according to the prospectus filed with the SEC.

Last week, Pavmed cut the exercise price on the Series W warrants, from $2.50 to $2.00 apiece, its second price cut since late last year. Originally exercisable at $5.00 apiece, the company slashed the price in half last December.

In November, Pavmed filed a 510(k) application with the FDA for its CarpX device, which is designed to be a minimally-invasive treatment for carpal tunnel syndrome.

Pavmed files FDA 510(k) for CarpX carpal tunnel device

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PAVmed

Pavmed (NSDQ:PAVM) said today it filed a 510(k) application with the FDA for its CarpX minimally invasive device designed to treat carpal tunnel syndrome.

The CarpX is a percutaneous device designed to allow the operating physician to relieve compression of the median nerve without a surgical incision. The system combines a balloon catheter with bipolar radio-frequency cutting electrodes and is positioned through guidance with ultrasound, the company said.

“I have had the opportunity to use Pavmed’s highly innovative CarpX device in pre-submission testing and am very impressed with its performance. As a busy hand surgeon, I strongly believe that CarpX will be a game-changer in the treatment of carpal tunnel syndrome, providing patients with a much less invasive option and significantly shorter recovery times than traditional open carpal tunnel surgery. I eagerly await CarpX’s regulatory clearance and the opportunity to offer this ground-breaking innovation to my patients suffering from carpal tunnel syndrome,” Dr. David Kelly of Gilbert, Ariz.’s Center for Dermatology and Plastic Surgery said in a press release.

Upon activation, the CarpX device creates a space within the tunnel to confirm the nerve is protected from the cutting electrode and decompresses the median nerve by dividing the transverse carpal ligament.

“We designed CarpX to closely mimic the anatomic results of traditional invasive carpal tunnel surgery but to do so much less invasively, using catheters, balloons, radiofrequency energy and other established tools that have contributed to the percutaneous and minimally invasive revolutions in the treatment of other conditions. Our balloon catheter device is designed to be inserted under the scarred ligament in a minimally invasive fashion, while pushing the nerve and tendons away. When activated, bipolar radiofrequency electrodes precisely cut the ligament from the inside out in a matter of seconds. The device design provides physicians with ongoing feedback to optimize the safety and completeness of the procedure,” Pavmed chief medical officer Dr. Brian deGuzman said in prepared remarks.

Pavmed said it is hopeful that the CarpX device can decrease costs and move procedures out of operating rooms, as well as decreasing postoperative pain and hospital stays before patients can return to their day-to-day lives.

“We are very excited to have reached this most important milestone in Pavmed’s corporate history. CarpX has become the most commercially promising and clinically exciting product in our pipeline and we believe it will revolutionize the treatment of carpal tunnel syndrome, a widely prevalent condition that exacts a significant clinical and economic burden on society in the U.S. and worldwide. Based on epidemiological and market research data we estimate CarpX’s addressable market opportunity to exceed $1 billion,” Pavmed chair & CEO Dr. Lishan Aklog said in a prepared statement. “As with all of our products, CarpX’s development and regulatory testing were performed using our unique business model focused on speed to market and capital efficiency. We are proud to have achieved this milestone within a timeframe and with capital expenditures to date that beat our model’s benchmarks. We believe we have assembled a strong submission and are targeting clearance in the first half of 2018. Upon successful regulatory clearance, we anticipate an aggressive commercialization strategy using well-established independent sales channels targeting the appropriate physician specialties.”

Earlier this month, Pavmed saw shares rise after the medical device maker beat expectations on Wall Street with its third quarter results

Pavmed shares climb after Q3 EPS beat

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