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Outset Medical Announces $125 Million Financing Led by D1 Capital Partners

Outset Medical, a leading medtech innovator delivering first-of-its-kind technology into the growing global dialysis market, today announced a $125 million Series E equity financing round led by D1 Capital Partners. Fidelity Management and Research Company, Partner Fund Management, Perceptive Advisors, funds advised by T. Rowe Price Associates Inc., also are participating in the financing.

Proceeds will be used to support commercial expansion of Outset Medical’s Tablo Hemodialysis System across the acute and chronic care markets in the United States. Designed to reduce the cost and complexity of dialysis, Tablo expands how, when, and where dialysis can be provided.

“We believe in Outset’s vision for technology-driven care delivery improvement, and Tablo’s ability to disrupt the dialysis market,” said Dan Sundheim, Founder of D1 Capital Partners. “With growing focus at the federal level on how to manage Chronic Kidney Disease, which is increasingly prevalent, we believe Tablo is the only device with the potential to transform the delivery of dialysis.”

Dialysis is delivered to more than 550,000 U.S. patients several times per week to remove waste products and excess fluid from patients with kidney failure. Although more than 85 million dialysis treatments take place in the United States each year at an estimated annual cost of ~$75 billion, little meaningful technology or service model innovation has been introduced in decades.

“Tablo’s unique, intuitive, all-in-one design offers healthcare systems, providers and patients a way to meaningfully improve the dialysis experience while also reducing costs,” said Leslie Trigg, Outset Medical’s Chief Executive Officer. “We thank our investors for their continued support and look forward to deploying this capital to significantly impact the future of dialysis care.”

About the Tablo Hemodialysis System

Tablo is an FDA-cleared enterprise solution for dialysis, designed specifically to reduce the cost and complexity of dialysis across all care settings. Requiring only an electrical outlet and tap water to operate, the mobile Tablo system frees patients and providers from the burdensome infrastructure required to operate conventional dialysis machines.  The machine’s integrated functionality enables it to serve as a dialysis clinic on wheels and enables providers to standardize to a single platform that can be used across a wide spectrum of care settings. Wireless data, sensor-based automation and an animated touchscreen make the system easy to learn and use.  Leading health systems and medical centers across the U.S. have adopted Tablo for hospital and clinic dialysis, and the U.S. Department of Health and Human Services (HHS) awarded a contract for the use of Tablo in communities hit by natural disasters.

Cooley LLP acted as legal advisor for Outset Medical in connection with the financing.

First Implantations with MOVE-C Cervical Disc Prostheses from NGMedical

NGMedical GmbH located in Germany has announced the worldwide first implantations of its new MOVE-C disc prosthesis. After receiving CE approval end of December 2019, the first MOVE-C cervical disc prostheses were implanted in January.

The well thought through instrument set and the anatomical design of MOVE-C were crucial for the smooth surgeries. MOVE-C combines the features of a second generation disc prosthesis with the simple implantation technique of a cervical cage. The prosthesis offers physiological motion in all 6 planes including axial damping with progressive resistance to motion. Furthermore, MOVE-C is the first prosthesis with additively manufactured titanium endplates and avoids the use of PE.

NGMedical is specialized in motion preserving spinal implants as well as intelligent solutions for fusion surgery. With an experienced team of specialists and in cooperation with experienced spine surgeons NGMedical works on well thought through and tested solutions for state of the art spine surgery. In the near future, the new cervical BEE cage with a sophisticated honeycomb structure, which is purely manufactured additively, will be available.

Leadership Team Expansion Announced by Command Medical: Includes William King & Chad Tremaroli

Command Medical Products has announced that William King and Chad Tremaroli are new additions to the Command Medical’s leadership team. King and Tremaroli Both filling new positions created to support the company’s focus on improved customer experience and sustaining the ongoing expansion of the organization.

William King joins Command Medical as the quality assurance and regulatory compliance manager. His prior role as quality systems and regulatory manager at Steris Isomedix bring excellent depth and experience in sterilization and regulatory compliance to the Command team. Bill’s previous positions at PerkinElmer and OMNIlife sciences support Command Medical’s strategic goals for optimization and improved customer experience in the quality and regulatory operations of the business. Bill has assumed the role of Command Medical’s management representative with the FDA and ISO notified body, SGS from Robert Wise. This transition of responsibilities will enable Robert to provide focused customer support in a variety of quality related contexts.

Chad Tremaroli has assumed the Director of Operations role at Command Medical’s Florida manufacturing facility. Previously, John Basham, who was also Director of Engineering, held this position. The splitting of this role into two separate functions aligns with Command Medical’s future strategic organizational structure. John will retain the Director of Engineering role as Chad focuses on operational improvements supported by his prior fourteen years’ experience working for Medtronic in senior leadership positions in logistics, distribution, continuous improvement and value stream management.

“It is an exciting time for Command Medical,” shared Jim Carnall, Command Medical’s president and COO. “Our vision to create a customer centric business is coming to fruition. Through transparent and responsive customer service, we are differentiating Command as a company that is truly focused on customer service beyond the traditional benchmarks of on time delivery and high quality. We offer direct communication to all department leaders and encourage open collaboration and sharing of knowledge with our clients. In order to support this while growing our business, we needed to add resources. The addition of Bill and Chad are key steps in our overall plan to meet our goal in providing legendary customer service.”

Glucagon Emergency Medicine Kit to Treat Life-Threatening Episodes of Low Blood Sugar

Fresenius Kabi announced today the availability in the United States of its Glucagon Emergency Kit, an FDA-approved and cost-effective alternative to treat severe hypoglycemic episodes in people with diabetes.

The kit includes Glucagon for Injection 1 mg and a prefilled glass syringe with 1 mL of Sterile Water for Injection, USP.

“For people with diabetes, a severe hypoglycemic episode can occur anywhere and at any time,” said John Ducker, president and CEO of Fresenius Kabi USA. “Our new Glucagon Emergency Kit allows clinicians flexibility and choice for treating patients experiencing severe hypoglycemia. This is another example of Fresenius Kabi’s commitment to providing cost-effective products that deliver life-saving care.”

The Glucagon Emergency Kit is designed to be convenient and easy to use. Patients can carry it with them, so it is available should they experience severe hypoglycemia. The bright orange case makes it easy for a patient or caregiver to find it and act quickly. To help make the Glucagon Emergency Kit more affordable, there is a co-pay assistance program for patients who qualify.

Fresenius Kabi is also making injection training kits available to health care providers to help educate patients. To learn more about the Glucagon Emergency Kit, please visit here.

 

 

New Scalable Options for Panther System Launches in the US and Europe

The Panther Scalable Solutions (PSS) portfolio are now commercially available in the United States and Europe, reports Hologic today. These new optional configurations, which represent Hologic’s next generation of molecular diagnostics innovation, will allow laboratories to scale their instrumentation to meet testing demands in both their current workflow and their future growth plans.

“Our laboratory partners seek continuing efficiency and consolidation, and we are observing that trend in real-time, with more Panther instruments in the field running multiple assays than ever before”

“Our laboratory partners seek continuing efficiency and consolidation, and we are observing that trend in real-time, with more Panther instruments in the field running multiple assays than ever before,” said Kevin Thornal, president, Diagnostic Solutions Division at Hologic. “In the tenth year since launching the Panther system, we are excited to add expanded capabilities to our market-leading molecular diagnostic platform.”

The Panther system, launched in Europe in 2010, offers random access and full automation for molecular testing. It provides a broad assay menu that includes tests for women’s health, sexually transmitted infections (STIs), respiratory health, and viral load, as well as Open Access functionality for laboratory-developed tests (LDTs). This broad menu enables labs to consolidate molecular testing onto a single platform.

Within Panther Scalable Solutions, the Panther system functions as the foundation for optional add-ons. These add-ons include Panther Fusion, which launched in 2016 and provides additional IVD menu and the Open Access™ functionality, the now available Panther Plus and Panther Link, as well as the upcoming Panther Trax.

Taken together, these configurable options address the needs of today’s laboratories, allowing them to increase operational capacity and testing volumes at their own pace while building on the flexibility and streamlined user experience they require. Panther Scalable Solutions allows laboratories to choose custom configurations that best suit their needs and testing volumes as they evolve over time. These new options expand upon the proven performance and reliability of the Panther system.

The new optional configurations include:

  • Panther Plus, which adds flexibility, capacity and throughput to the existing Panther system. With Panther Plus, labs can load more consumables directly on the instrument, allowing even greater walkaway time (up to 13.5 consecutive hours). Both fluids and waste can be changed while tests are in process, and an option for automatic liquid waste disposal is available. These features allow an additional 210 tests to be run in 24 hours, providing a total throughput of greater than 1,200 patient samples in that time. Panther Plus is FDA-approved and CE-Marked and is now available in the United States and Europe.
  • Panther Link is a software solution that provides additional efficiencies by creating a virtual connection that allows multiple Panther instruments to communicate with one another and function within a singular, streamlined workflow. Linked instruments can share information such as reagent kits and reflex test orders, enabling more efficient reagent utilization and improved turnaround time. A dashboard command feature allows technicians to monitor instrument inventories, maintenance tasks and test results on a single screen from a centralized location. Panther Link is FDA-approved and CE-Marked and is now available in the United States and Europe.

In addition, Hologic is developing Panther Trax, which will offer the ultimate in lab automation by physically and electronically linking multiple Panther instruments together into a single, powerful workcell that allows labs to increase testing volumes without increasing staff. Panther Trax is expected to be available in the United States and Europe later in 2020.

Use of the Accuray TomoTherapy System for Advanced Rectal Cancer to Improve Treatment Efficacy and Reduce Side Effects

Accuray Incorporated announced today that two new studies demonstrate the benefits of the TomoTherapy System in the treatment of advanced rectal cancer. Radiotherapy, with or without chemotherapy, followed by surgery is the standard of care in the treatment of locally, advanced rectal cancer. However, radiation delivered to surrounding organs, such as the bowel and bladder, may lead to life-changing side effects, making it critically important for the radiation to be delivered with extreme accuracy and precision. The TomoTherapy platform, including the next-generation Radixact® System, is the only system available that is capable of helical radiation delivery continuously delivering image-guided, intensity-modulated radiation therapy (IG-IMRT) from a full 360 degrees around the patient as the treatment table also moves — providing greater control of the radiation dose so it conforms precisely to the tumor and minimizes dose to healthy tissue.

Patients enrolled in the two studies received simultaneous daily radiation and a targeted radiation boost over a 25-day time period. The study investigators found that the TomoTherapy platform’s unique architecture enabled the delivery of a high dose of radiation, directly to the tumor, through the integrated boost of radiation, while minimizing radiation to organs in close proximity to the targeted tumor. As a result, patients in the studies experienced improved treatment results and reduced side effects. These study outcomes compare favorably to conventional radiotherapy, based on results from other studies.

Novel treatment approach shows promising results
The clinical teams at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland and the Clinica Luganese in Lugano, Switzerland, reported on their retrospective analysis of patients with advanced rectal cancer treated with TomoHelical™. The study titled, “Neoadjuvant chemoradiotherapy delivered with helical tomotherapy under daily image guidance for rectal cancer patients: efficacy and safety in a large, multi-institutional series,” was published in the Journal of Cancer Research and Clinical Oncology, and found:

  • Treatment with TomoHelical is safe, with low rates of severe toxicity
    • Radiation delivered with helical TomoTherapy following daily imaging with the platform’s integrated imaging capabilities allowed for the reduction of treatment margins around the tumor, so less normal tissue was irradiated. The authors highlight a “clear reduction in the rates of acute and late non-hematological toxicities” when compared to a randomized trial evaluating the use of 2D- or conformal 3D-RT techniques, published in the New England Journal of Medicine (NEJM)[1]
  • The four-year outcomes showed excellent local tumor control and disease-free survival rates of 88.4 percent and 74.6 percent, respectively
  • A significantly higher rate of pathological complete response (pCR) was reported in the group of patients who received a simultaneous integrated boost compared to those who did not receive the boost. pCR is an indication of how well the treatment is working, with those patients achieving a pCR experiencing reduced rates of local recurrence and better overall survival

“The results of our analysis are encouraging because they indicate that patients with advanced rectal cancer may have a better option for effectively treating their disease. Further studies are needed, however, we believe that highly conformal radiation doses delivered with TomoHelical in combination with daily image guidance may become the new standard of care for pre-surgical treatment in patients with advanced rectal cancer,” said Dr. Berardino De Bari, assistant professor and radiation oncologist in the radiation oncology department, CHUV.

Listen to Dr. De Bari share his experience using the TomoTherapy System at this link.

Targeted radiation boost helps maintain patient quality of life
In another study, clinicians at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing, People’s Republic of China, published results of their advanced rectal cancer study titled, “Concomitant dose escalation with image-guided TomoTherapy® in locally advanced mid-low rectal cancer: a single-center study,” in Cancer Management and Research. Highlights of the study include:

  • The clinical team used TomoHelical™ to simultaneously deliver daily radiation treatments and a targeted radiation dose boost to the primary tumor, to improve outcomes and quality of life in patients with advanced rectal cancer
  • TomoHelical treatment was able to significantly reduce the volume of the tumor, while minimizing dose to surrounding organs-at-risk. This enabled surgeons to perform sphincter-preserving surgery while removing the remaining tumor in 80.1 percent of patients in the study, thereby increasing the chance of maintaining normal bowel function and preserving quality of life
  • Treatment resulted in positive outcomes with 95.5 percent of patients showing local tumor control and 70.9 percent exhibiting no signs of cancer five years after the radiation therapy procedure
  • At the study authors’ institution, the outcomes associated with TomoHelical treatment were superior to that with their non-dose-escalated conventional approach

“Surgical treatment of mid-low rectal cancer offers the best option for long-term management of the disease, though can be challenging because of the risk of damaging surrounding organs and the resulting side effects, including bleeding, fecal incontinence, sexual and urinary dysfunction, and pelvic pain,” said Fuquan Zhang [professor and chairman of the radiation oncology department]. “With the simultaneous use of daily radiation and a targeted boost, delivered with TomoHelical, we were able to effectively reduce the tumor volume while preserving the sphincter and its functionality for the majority of patients in the study,” continued Ke Hu [professor and vice chairman of the radiation oncology department].

Listen to Prof. Zhang share his experience using the TomoTherapy System here.

“These most recent studies are a valuable addition to the available literature on the use of chemoradiation prior to surgery in the treatment of advanced rectal cancer. The treatment outcomes are extremely promising and may offer new hope to patients whose previous options were limited,” said Fabienne Hirigoyenberry-Lanson, Ph.D., vice president global medical and scientific affairs, at Accuray. “The treatment regimens described in the studies reinforce the benefits of the unique capabilities of the TomoTherapy platform and what we would also expect to see with the Radixact® System. With TomoHelical mode, clinical teams were able to effectively and efficiently treat the rectal tumors while minimizing side effects and importantly, their potential impact on the quality of life.”

 

Lumos Diagnostics Secures $15M in Series A Funding from Planet Innovation

Lumos Diagnostics announced the closing of U.S. $15 million in Series A funding from Planet Innovation, an Australia-based healthtech innovation and commercialization company.

Lumos Diagnostics advises funding will support the international commercial expansion of the FebriDx® rapid point-of-care (POC) test, the FebriDx U.S. FDA pivotal clinical trial, and additional development and manufacturing resources for the company’s expanding full-service POC business.

Lumos Diagnostics, a spinout from Planet Innovation, merged with RPS Diagnostics in May 2019, creating a diverse healthcare company that combines the FebriDx test and commercial experience with a novel and proprietary digital reader platform. Sam Lanyon, chairman of the board for Lumos Diagnostics and co-chief executive officer for Planet Innovation states, “Planet Innovation is focused on breakthrough technology and making investments that will have a global impact on healthcare. It is obvious that Lumos Diagnostics is poised for rapid growth and Planet Innovation is keen to support and accelerate the process.”

FebriDx is a rapid POC test that provides clinicians with an in-office assessment of the body’s immune response to acute respiratory infection (ARI). More than 50% of all unnecessary antibiotic prescriptions are for outpatient ARIs which may be associated with nonspecific flu-like symptoms, including fever, sore throat, cough, nasal congestion, and fatigue. Only bacterial infections benefit from antibiotic treatment. The single-use FebriDx test identifies patients of all ages within 10 minutes who have a clinically significant underlying infection and aids in the differentiation of viral and bacterial ARIs through the simultaneous detection of both Myxovirus resistance protein A (MxA) and C-reactive protein (CRP) directly from a fingerstick blood sample.

MxA is highly specific and elevates in the presence of acute viral infection while CRP is a nonspecific inflammatory protein that elevates in the presence of clinically significant infection. The simultaneous, combined interpretation of both MxA and CRP leads to sensitive and specific test results. With a 97-99% negative predictive value for ruling out bacterial infections, the FebriDx test may help to limit the amount of unnecessary antibiotic prescriptions that can lead to avoidable adverse reactions and antibiotic resistance, resulting in lower costs.

Robert Sambursky, MD, president, and chief executive officer of Lumos Diagnostics states, “FebriDx helps advise antibiotic decisions for outpatient ARI while saving clinician time, improving workflow and reducing overall costs. The novel digital reader technology that Lumos offers as part of our complete POC service solution will be used in the next generation digital FebriDx test, providing faster time to results, identification of the rare co-infection and enhanced objectivity of test result interpretations.”

JenaValve Technology Closes $50 Million Financing

JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial Transcatheter Aortic Valve Replacement (TAVR) System for the treatment of aortic valve disease, announces that it has raised $50 million in an equity financing led by Bain Capital Life Sciences.

Additional participants in the financing included existing investors Andera Partners, Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners. The Company also announces the appointment of Andrew Hack, MD, PhD, Managing Director of Bain Capital, to the JenaValve Board of Directors.

John Kilcoyne, JenaValve’s Chief Executive Officer said, “We are pleased to complete this financing led by new investor Bain Capital Life Sciences, a well-respected name in healthcare, as well as strong participation from our existing venture investors.  This announcement comes on the heels of receiving Breakthrough Device designation from the U.S. Food and Drug Administration (FDA), which allows for priority review of our Align Clinical Trial for the treatment of symptomatic, severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. Our TAVR system is differentiated in that no other transcatheter valve device has FDA approval for patients suffering from severe AR who are at high risk for surgery, which we believe is a multi-billion-dollar market opportunity. This financing supports our ongoing clinical program and plans to file for U.S. Humanitarian Device Exemption (HDE) approval in the second half of 2020.”

JenaValve is conducting a global multicenter clinical program for the treatment of patients with severe AR and AR-dominant mixed aortic valve disease who are at high risk for surgery. Following the completion of the HDE portion of the trial, patient enrollment will continue in support of submitting a Premarket Approval (PMA) application to the FDA under the Breakthrough Device program. The Company also anticipates filing the JenaValve® for CE mark approval for both aortic stenosis and aortic regurgitation in the second half of 2020.

“We welcome Dr. Hack to our Board and look forward to Bain Capital’s contribution to governance and strategy,” added Mr. Kilcoyne. “Andrew’s industry knowledge and experience, as well as his success as an institutional investor and chief financial officer will add valuable perspectives to our Board.”

Dr. Hack commented, “I’m delighted to join the JenaValve Board as the Company works to gain approval for a solution to a significant unmet medical need. JenaValve’s focus on advancing a breakthrough technology with the ability to improve patient lives embodies the characteristics we seek at Bain Capital Life Sciences. We are committed to providing both financial assistance and oversight in support of JenaValve’s success.”

Dr. Hack has served as a Managing Director at Bain Capital Life Sciences since 2019. He previously served as Chief Financial Officer of Editas Medicine (Nasdaq: EDIT) and as a healthcare portfolio manager at Millennium Management. Prior to that, he was a securities analyst at a number of healthcare-focused hedge funds and investment banks. Dr. Hack received an MD and a Ph.D. in molecular genetics and cell biology from the University of Chicago.

EVEON Accelerates its Developments and Expands its Range of Medical Devices

EVEON positions itself as a key player to make easily accessible new molecules, particularly biologics, to the largest number of people.

EVEON also enables administration methods that make life easier for patients by contributing to new care pathways. The challenges induced by healthcare reimbursement systems can be reduced by medical devices more innovative and adapted for patients and healthcare professionals.

EVEON focuses on the design, development and industrialization, with its partners of the JBT HubUp alliance, of upgraded medical devices for both drug preparation and drug delivery. EVEON offers tailor-made solutions for applications at home or in a medical environment, based on a unique technology platform Intuity®. Safety and ease of use are the basis of its developments.

In 2019, EVEON produced the first functional models of Intuity® Ject, reaching a new stage in its development and growth. Different versions of this device are being prepared for reconstitution and injection of drugs. EVEON has also developed, based on its patented technologies, a new automated medical spray device, Intuity® Spray, for the delivery of high viscosity treatments through the respiratory, dermatological or oral routes. These devices are in addition to the Intuity® Mix device that allows the automatic reconstitution of lyophilized drugs.

At the end of 2019, Forbes magazine ranked EVEON 3rd most inventive company in France in the medical technologies category.

“In 2019, with the confidence of our customers and the mobilization of our teams and partners, we have reached new milestones and accelerated our developments. Thanks to these innovations, we are already planning new evolutions in 2020 for EVEON both in terms of technology and of overall performance,” said Vincent TEMPELAERE, CEO of EVEON.

 

Electronic Patch to Improve Chronic Wound Monitoring Announced by Graphene Flagship

February 5, 2020

Electronic Patch: Graphene Flagship associated member, Grapheal has developed a pioneering wearable patch for the remote monitoring of chronic wounds.

The flexible and transparent graphene-based biosensor enables doctors and nurses to provide hyper-responsive treatment of chronic wounds. The device will be showcased at Deep Tech EU, at Mobile World Congress 2020, held in Barcelona, Spain on February 24 to 27, 2020.

Evidence suggests effective wound care will become critical for healthcare in Europe as the population ages and the prevalence of chronic wounds increases. The growing frequency of diabetes in Europe is exacerbating the situation, with approximately 5.5 percent of 60 million diabetics in Europe developing a foot wound.

Chronic wounds can take months or even years to heal. In 20 percent of the cases, the injury never heals and can lead to limb amputation. This dramatic consequence is on the rise, with a 19.4 percent increase in limb amputations during 2014-2017 compared to 2010-2013.

At Deep Tech EU, the largest showcase of technologies born out of European Flagships, Grapheal, a spin-off from CNRS-Grenoble (France) will demonstrate how its wound monitoring technology will change the way the healthcare industry deals with the chronic wound epidemic.

Connected to a smartphone, Grapheal’s wearable patch enables continuous monitoring of wounds, to empower caregivers and wound sufferers with a smart and accurate assessment tool. The wound patch measures and stores the bio parameters of the wound and communicates this data to the cloud via a smartphone app. This real-time connectivity ensures nurses and doctors can be alerted to early stages of infection and other complications.

“Our patented formula uses Graphene-on-polymer, in a non-invasive way, to actively react to any changes to the wound”, explained Vincent Bouchiat, Grapheal CEO. “As an atomically thin material, graphene’s electrode conductivity will change according to any physicochemical change, enabling faster detection of problems for patients.”

“Our patch can adapt to any shape of the wound, using Graphene’s thin and flexible properties. In fact, the non-invasive nature of the patch actively stimulates wound healing — and we have led eight preclinical studies to prove its biostimulation properties.”

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