Lucid Diagnostics enrolls first patient in study of esophageal DNA test

Pavmed (NSDQ:PAVM) subsidiary Lucid Diagnostics announced today that investigators enrolled the first patient in a stud of its EsoGuard.

Investigators at the Louis Stokes Cleveland Department of Veterans Affairs Medical Center (Cleveland VA) enrolled the patient in a U.S. Defense Dept. (DoD)-funded study of the EsoGuard esophageal DNA test for at-risk patients with gastroesophageal reflux disease (GERD).

Lucid Diagnostics is providing EsoCheck esophageal cell collection devices for the study and will perform EsoGuard testing on the samples collected. Cleveland VA gastroenterologist Dr. Katarina B. Greer serves as the study’s principal investigator.

“We are proud to be partnering with Dr. Greer and the Cleveland VA on this important investigator-initiated clinical study,” Lucid Diagnostics Chairperson and CEO Dr. Lishan Aklog said in a news release. “The study will add important clinical evidence on the impact of EsoGuard in enhancing early detectio…

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PAVmed completes first-in-human implantations of its intraosseous infusion system

PAVmed (Nasdaq:PAVM) announced today that it successfully completed the first human implants of its PortIO intraosseous infusion system.

New York-based PAVmed designed its PortIO system with an implantable intraosseous vascular access device and insertion kit. Instead of a catheter located in a vein, the system has a short extension from the device inserted by a physician into a bone, leaving the device to reside completely beneath the skin.

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

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Pavmed appoints Shaun O’Neil as chief operating officer

Pavmed (NSDQ:PAVM) this week appointed Shaun O’Neil as executive VP and chief operating officer.

O’Neil has served as Pavmed’s chief commercial officer and executive VP of business development since joining the company in 2018. Through his new roles, he will be responsible for overseeing diverse corporate operations and commercial activities within Pavmed and its subsidiaries. He will serve on the company’s executive committee as an executive officer.

“I am energized to take on this expanded role at such an exciting time for PAVmed and its subsidiaries,” O’Neil said. “We are in as strong a position as ever to execute on our strategic plan, drive commercialization of our products and grow long-term shareholder value. That strength is built on a solid balance sheet, groundbreaking technologies, and the best team in the industry. I look forward to helping execute on our vision to transform PAVmed into a leading global medical technolo…

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Pavmed’s Lucid Diagnostics acquires CapNostics and its esophageal cell collection device

Pavmed (NSDQ:PAVM) announced today that its Lucid Diagnostics subsidiary entered into an agreement to buy CapNostics.

Lucid Diagnostics, a wholly-owned subsidiary of Pavmed, entered into a definitive membership interest purchase agreement with Martin Von Dyck, the sole member and owner of North Carolina-based CapNostics, according to a news release.

CapNostics manufactures the FDA-cleared and CE-marked EsophaCap non-endoscopic esophageal cell collection device that has been used in pre-commercial clinical research of esophageal precancer biomarkers at major academic medical centers.

Lucid Diagnostics, which recently publicly filed a registration statement related to a proposed initial public offering (IPO), concurrently entered into an exclusive long-term consulting agreement with Von Dyck, as well as an exclusive long-term manufacturing agreement with the EsophaCap contract manufacturer.

Financial details of the acquisition were not disclosed. Read more

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Pavmed subsidiary Lucid Diagnostics files registration statement for IPO

Pavmed (NSDQ:PAVM) subsidiary Lucid Diagnostics announced that Lucid publicly filed a registration statement related to a proposed initial public offering (IPO).

The number of shares of common stock and the price range for the offering have not yet been determined, according to a news release. Lucid Diagnostics intends to list its common stock on the Nasdaq market under the “LUCD” ticker.

Cantor Fitzgerald & Co. and Canaccord Genuity LLC will act as joint book-running managers for the proposed offering. BTIG, LLC and Needham & Co., LLC will act as co-lead managers for the proposed offering.

In February of this year, PavMed announced that Lucid would spin off into a separate public company “if favorable market conditions continue to hold, whether it be through an initial public offering (IPO) or a business combination with a healthcare special purpose acquisition corporation.”

At the time of announcing the planned sp…

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Lucid Diagnostics gains CE mark for esophageal device

Lucid Diagnostics has received the CE mark for its EsoCheck esophageal cell collection device, its parent company announced today.

EsoCheck is an FDA-cleared, swallowable balloon capsule catheter that enables a clinician to sample surface cells from the esophagus in a less than five-minute, non-invasive office procedure. Lucid touts EsoCheck as the only such device capable of doing so in an anatomically targeted fashion, without sample dilution or contamination.

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

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PAVmed wins CE mark for carpal tunnel device

(Image courtesy of PAVmed)

PAVmed (NSDQ: PAVM) today announced that it has received the CE mark for its CarpX minimally invasive carpal tunnel device.

EU-based Notified Body TÜV Rhineland LGA Products GMBH issued CE certificate, effective May 24, 2021, the company noted. CarpX may now be marketed in CE Mark European countries, which include the European Economic Area (the EU, Norway, Iceland and Lichtenstein), Switzerland, and, until July 1, 2023, the U.K.

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

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DTW Podcast: Geoff Martha updates Medtronic’s new course; AJAX CEO Duke Rohlen is funding innovation differently

Medtronic CEO Geoff Martha and Ajax CEO Duke Rohlen share insights and wisdom on this episode of the podcast.

Less than a year into his role as CEO, Geoff Martha and the Medtronic leadership has overseen a significant reorganization of medtech’s largest player.

In our closing keynote conversation, Martha says the company is clearing a minor COVID-19 bump and sees open road for the company to continue to grab share from competitors.

Martha details what products are gaining the most traction while also identifying those that still have some ground to gain.

We also discuss: When it may bring its renal denervation project to the FDA Why Hugo the surgical robot will be worth the wait (and why development has taken more than a decade) Whether or not Medtronic will collaborate more with private equity firms, early-stage incubators and maybe even SPACs? What will the company’s acquisition strategy look like in 2021. And why. Why the price-cutting for drug-eluting …
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PavMed to spin off subsidiary Lucid Diagnostics

Pavmed (NSDQ:PAVM) announced today that its majority-owned subsidiary Lucid Diagnostics will spin off into a separate public company.

In a news release, Pavmed said Lucid Diagnostics intends to spin off if favorable market conditions continue to hold, whether it be through an initial public offering (IPO) or a business combination with a healthcare special purpose acquisition corporation.

Lucid Diagnostics’ board of directors concluded that the move, a long-contemplated step, Pavmed said, will be necessary to help it fulfill its long-term potential as it seeks to unlock its present value and execute on a major new commercial initiative.

Pavmed said in the release that it believes a Lucid spin-off would be in the best interests of the company and its shareholders, while Pavmed will remain Lucid’s largest shareholder following any such transaction.

Lucid’s new commercial initiative is set to accelerate the commercia…

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Pavmed closes $12.4m offering

Pavmed (NSDQ:PAVM) announced last week that it closed a registered direct offering of common stock shares worth $12.4 million.

New York-based Pavmed’s previously announced offering included 6 million shares of common stock at a price of $2.24 per share, priced at-the-market under Nasdaq rules, according to a news release.

The company estimates that the net proceeds collected through the offering will reach $12.4 million after deducting the placement agent fees for Maxim Group LLC and other offering expenses.

Pavmed intends to put the proceeds toward working capital, general corporate purposes and for repaying a portion of its outstanding convertible notes.

The company raised $7.8 million in August 2020, having previously raised $4 million in May 2020. In April, the company received FDA 510(k) clearance for its CarpX minimally invasive carpal tunnel device.

Earlier in 2020, Pavmed confirmed an FDA breakthrough device designation for it…

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Pavmed raises $7.8M

Pavmed (NSDQ:PAVM) filed an SEC Form D to confirm the sale of $7.75 million in an offering of debt and options/warrants to purchase other securities.

In selling the $7.75 million, New York-based Pavmed reached its total offering amount in the new notice, which made its first sale on Aug. 5. Pavmed did not intend for the offering to last for more than one year, and it ended up lasting for less than one week.

The offering, which required just one unnamed investor, is not being made in connection with a business combination transaction, such as a merger or acquisition, according to the filing.

Pavmed did not specify its intended use of proceeds, having previously raised $4 million in May. In April, the company received FDA 510(k) clearance for its CarpX minimally invasive carpal tunnel device.

Earlier this year, Pavmed confirmed an FDA breakthrough device designation for its Lucid Diagnostics subsidiary’s EsoGuard esophageal DNA test and entered into…

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