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From Slaying to Slayed: Avail Abruptly Shuts Down
MD+DI had recently highlighted Avail Medsystems as a private medtech company that was slaying in 2023.
Avail Medsystems, one of the 23 private medtech companies poised to slay in 2023, shut down this week abruptly.?Sources who were employed by the Santa Clara, CA-based company confirmed to?MD+DI that it shut down Thursday.
Avail was born during the pandemic in response to a need for connecting medical device sales reps with operating room teams in a virtual environment at a time when reps were unable to access the OR. The company?developed a consistent, mobile,?hardware platform with integrated software into operating rooms, audibly and visually connecting remote participants and serving as the hub for advanced digital capabilities including AI and machine learning, in a secure cloud-based digital telepresence network.?The Avail platform was intended to medtech companies and healthcare professionals to collaborate, educate, and share surgical and medtech expertise between operating rooms and remote locations in real time.
MD+DI?named Avail as one of 23 private medtech companies expected to slay in 2023, based on a successful 2022. The company was?awarded a national?group purchasing agreement for telehealth/telemedicine?with Premier earlier this year. CEO Daniel Hawkins,?participated in a keynote panel session at Life Science Intelligence’s (LSI) Emerging MedTech Summit USA 2023?alongside Frederic Moll, MD, chief development officer at Johnson & Johnson who is?widely recognized as the father of robotic surgery. Also, in August, Smith + Nephew?published a case study demonstrating how?Avail's?telepresence technology positively impacted an R&D lab?that Smith + Nephew hosted.
Most recently, in October, Avail launched?several significant enhancements to its?telepresence platform, including a new capability to serve as an application platform in the OR. This new capability was meant to enable?medical professionals and surgical teams to collaborate during procedures remotely while leveraging the latest innovations in healthcare software including applications utilizing machine learning, AI, and workflow process software. Avail also announced significant upgrades to its software used by medical professionals outside the OR to join procedures virtually from anywhere, expanding their ability to connect and collaborate with surgical teams.
Through a partnership with?ORtelligence, the ORtelligence Rep+?software was made available to surgical teams and medtech professionals collaborating via the Avail platform. Rep+ is a surgical software process solution designed to connect?ORs to medtech?industry expertise and facilitates the delivery of support and training to surgical teams, even when representatives are not physically present in the OR. The software delivers on-demand virtual expertise with support for instrument identification, location, and usage instruction.
The company noted at the time that Rep+ was the first?third-party software application available through Avail, which was expected to grow with a library of curated cloud and/or locally based software applications designed to provide opportunities to enhance surgical procedures and deliver efficiencies for device manufacturers, physicians, and patients. Avail also indicated that it would add more third-party applications to its platform in the future, which might have included?workflow software, machine learning, AI applications, software as a medical device, or software that partners with smart devices. These applications would have been able to leverage the cameras, audio, monitor and computing on the Avail console without the need for their own additional equipment.
"We've heard from customers that third-party software hosting capabilities within the Avail platform would improve the ability for MedTech and healthcare to combine human and technological capabilities in the OR,"?Hawkins said in a news release Oct. 17. "Today is an exciting first step for Avail to be that conduit for the rapidly growing industry of clinical- and process-flow-driven software that will enhance clinical competencies and improve efficiencies in the OR."
There has been speculation that the company was trying to raise capital to maintain its growth but was unsuccessful. MD+DI will update this story if additional details become available.
J&J Sheds Light on Plans for Surgical Robot
Roughly two years ago, Johnson & Johnson delayed plans for its Ottava Surgical Robot. Now the company is ready to push forward with the technology.
By Omar Ford
Johnson & Johnson along with Medtronic were poised to be serious competitors to Intuitive Surgical in the surgical robotics space.
But a delay?around the same time Medtronic announced winning a CE Mark for its Hugo Robotic-Assisted Surgery platform derailed New Brunswick, NJ-based J&J’s plan to get its Ottava platform onto the market.
Now J&J is providing an update regarding Ottava. Last week the company said it has plans to submit an IDE application to FDA for the second half of 2024 to initiate clinical trials.
The company’s Ottava technology incorporates four robotic arms into a standard-size surgical table. J&J said this unified architecture allows for an invisible design, with the robotic arms available when needed or stowed under the surgical table when not. The design removes barriers to movement and collaboration in robotic operating rooms, according to the company.
The system’s “twin motion” feature – the unified movement of the table and the robotic arms – is designed to allow surgical teams to address important clinical needs during surgery, such as the ability to reposition a patient without interrupting the procedure.
“Today, the majority of operating rooms (OR) are not robotic because they were not built with a robot in mind,” said Dr. Eduardo Parra-Davila, a Colorectal and General Surgeon at the Palm Beach Digital Institute. “The industry needs a system that is adaptable, easy to use in any OR in the world, and maintains space in the OR. As surgeons, we need space to improve the workflow in the OR, increase safety, and enable 360-degree patient access so we can perform at the capacity that we would like to. That’s where Ottava comes in. Ottava offers a unique design that incorporates into any OR and allows surgeons to do what they would like to do and know how to do, which is focus on the patient.”
The State of Surgical Robotics
Intuitive has been relatively unchallenged in the laparoscopy space for surgical robotics since it received a nod from FDA for the da Vinci in 2000. And although Dublin-based Medtronic has CE mark for Hugo it hasn’t yet secured approval from FDA.
Nearly a year ago, Medtronic announced it was enrolling patients in a clinical trial of Hugo. Medtronic had previously delayed the program to make changes because of physician feedback.
J&J made a significant push into the surgical robotics space in 2019. First, the company made plans to acquire Auris Health for $3.4 billion. Auris has the Monarch Platform, an FDA-cleared system used in bronchoscopic diagnostic and therapeutic procedures.
J&J closed out 2019 by acquiring the remaining stake in Verb Surgical, a robotics-joint venture it held with Verily Life Sciences.
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Acutus Medical Lay off 65%, Report Corporate Restructuring
The restructuring will make the company a contract manufacturing business focused on Medtronic’s left-heart access products.
Acutus Medical today announced it will be cutting its workforce by 65% as part of a corporate restructuring to move the company into a contract manufacturing business. The shift, Scott Huennekens, Chairman of Acutus, said, came after an extensive review by the company’s board of directors in an effort to streamline operations.
Acutus Medical today announced it will be cutting its workforce by 65% as part of a corporate restructuring to move the company into a contract manufacturing business. The shift, Scott Huennekens, Chairman of Acutus, said, came after an extensive review by the company’s board of directors in an effort to streamline operations.
With the change, the new business model will solely support the manufacturing and distribution of Medtronic’s left-heart access products to capitalize on potential earnout payments from the company. Acutus sold its left-heart access portfolio to Medtronic in 2022 for $50 million and has since brought in tens of millions in milestone payments from the deal. According to the Asset Purchase Agreement, the company is eligible to receive net-sales earnouts that include 100% of total net end-user sales in year one, 75% of total net end-user sales in year two, and 50% of total net end-user sales in years three and four.
The company reported that it intends to wind down its electrophysiology (EP) mapping and ablation business, including the AcQMap Mapping System, the AcQMap 3D Mapping Catheter, the AcQBlate Force-Sensing Ablation Catheter, the AcGuide Max 2.0 steerable sheeth, and associated accessories. Acutus will continue to support AcQMap procedures with a small group of therapy managers through Nov. 30, 2023.
“In light of the current financing environment and the capital investments required to achieve leadership in the electrophysiology (EP) market, we have concluded that the optimal use of the company’s resources is to reallocate capital from our mapping and ablation business to the manufacturing of left-heart access products for Medtronic, which we believe will maximize the potential for future earnouts and cash flow,” Huennekens said.
As part of implementing its corporate restructuring, which the company has already started, 65% of its current workforce will be laid off. According to the most recent annual report, Acutus listed 225 employees at the end of 2022, meaning the layoffs could potentially affect around 146 workers.
“The realignment of resources and corporate restructuring unfortunately impacts our team,” said David Roman, Acutus president and CEO. “It is undoubtedly difficult to part with our valued and highly talented colleagues who have made substantial contributions to our company. I want to thank each one of them for their dedication to Acutus and our mission.”
Company officials said they expect to complete the restructuring in the first quarter of 2024.
After the restructuring, the company will become a contract manufacturing business with positive cash flow generation potential over the next several years and will continue to work with strategic and financial advisors to maximize the benefits of the new model, according to Acutus.
Q323 Financial Report
Along with news of the unexpected plan to restructure, the company also reported its Q323 financial results which included an increase of 44% in revenue compared to the year prior, from $3.6 million in Q322 to $5.2 million in Q323. The company put the improvement year-over-year to sales through its distribution agreement with Medtronic, higher capital sales, and increases in service, rent, and other revenue.
There were also significant year-over-year reductions in both GAAP and non-GAAP operating expenses and cash burn — negative 64% in Q323 compared to a negative 91% in Q322. Operating expenses also saw reductions in 2023s third quarter, with the company only spending $12.2 million compared to $15.6 million for the same quarter last year (non-GAAP numbers were $11.1 million in Q323 compared to $15.2 in Q322.)
Cash, cash equivalents, marketable securities, and restricted cash were reported as $45.5 million as of Sept. 30, 2023.
FDA Warns of Mesh Use in Breast Surgery after BD Updates Labels
Currently, there are no surgical mesh products cleared or approved by FDA for use in breast surgery.
FDA last week released a statement informing healthcare providers about labeling updates for Becton, Dickinson and company (BD) mesh products, reminding individuals that the use of surgical mesh products in breast surgery has not been determined by the administration to be safe and effective.
The labels were updated on the following products:
The products, which are cleared for the repair and reinforcement of soft tissue where weakness exists, saw updates to their warnings and precautions.
FDA said that it is aware of increased use of surgical mesh products in breast surgery but that “the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined,” according to the statement. Currently, there are no surgical mesh products cleared or approved by FDA for use in breast surgery.
The administrations stance affirms previously communicated recommendations from the General and Plastic Surgery Devices Panel held March 25-26, 2019. Of note, FDA is not recommending reoperation or removal of implanted surgical mesh in asymptomatic patients.