Reprieve Cardiovascular

In July 2020, Reprieve Cardiovascular completed a Series A round financing of $15 million. Reprieve Cardiovascular is a medical device company focused on automated fluid management technologies for acute heart failure treatment.  

Element Science

In March 2020, Element Science announced that it had raised a $145.6 million Series C financing. The Company is a health technology company pioneering a next-generation digital wearable platform focused on high-risk cardiovascular patients transitioning from the hospital-to-home.

Cathworks

In February 2019, Cathworks announced a $30 million Series B financing led by Deerfield. CathWorks is a medical technology company focused on applying its advanced computational science platform to optimize prophylactic cranial irradiation therapy decisions and elevate coronary angiography from visual assessment to an objective fractional flow reserve-based decision-making tool for physicians.

Farapulse

Farapulse is developing catheter-based tools designed to treat atrial fibrillation. The Company aims to advance tissue-selective pulse field ablation therapy on catheter and surgical platforms for both endocardial and epicardial approaches.

Axon Therapies

Axon Therapies is an early-stage company developing a novel neuromodulation approach to treat heart failure.

Afib treatment advances publish in prominent medical journals

Real-time feature of Acutus’ AcQMap results in improved patient outcomes

A clinical trial investigating Acutus’ AcQMap showed that this novel imaging and mapping system safely guided cardiac ablation resulting in a 12-month freedom from recurrent atrial fibrillation (AFib) in 73 percent of patients with persistent atrial fibrillation.

The results, published in the July 1, 2019 issue of the Journal Circulation: Arrhythmia and Electrophysiology were first reported earlier this year in a late-breaking trial at the 24th Annual AF Symposium in Boston.

Known as UNCOVER-AF, the trial prospectively studied the safety and efficacy of the AcQMap in 127 patients at 13 sites in Europe and Canada – 98 percent of whom achieved a normal heartbeat upon completion of the procedure.

Characterized as an irregular heartbeat, AFib is the most common type of heart arrhythmia and could greatly increase a person’s risk of developing a severe stroke. Cardiac ablation is a procedure that can reduce the risk, yet traditional ablation procedures often fail to achieve long-term absence of AFib, resulting in repeat ablation procedures.

With its precision ultrasound and high definition re-mapping capabilities, AcQMap helps inform physicians in real time who can strive to improve outcomes by checking their work after each ablation.

Adapted from Acutus’ news release: Publication of UNCOVER AF Study in Circulation Demonstrates Impact of Charge Density Mapping During AF Ablation

Acutus has been a Deerfield portfolio company since 2016.  

Farapulse PFA shown as potential alternative to existing ablation procedures

A method of non-thermal field ablation demonstrated safety and efficacy in clinical trials comparing outcomes of the modality to those seen with traditional thermal approaches in patients with paroxysmal atrial fibrillation, or episodic AFib.

The results of the first-in-human trial were reported in an online early version of the manuscript that is slated to publish in the Journal of the American College of Cardiology.

Called pulsed field ablation (PFA), the alternate modality was shown to successfully target heart tissue without damaging adjacent structures like the esophagus or phrenic nerve – a shortcoming of standard ablation therapies, including radiofrequency (via heat) and cryotherapy (by way of freezing).

In 81 patients, 100% of pulmonary veins (PV) were specifically isolated with three minutes of PFA time per patient. Furthermore, long-term remapping procedures demonstrated that the rates of durable PV isolation improved with successive waveform modifications with the most optimized PFA group demonstrating 100% durability.

The rate of primary safety events was low at 1.2%, and with no subsequent primary adverse events during follow-up.

Farapulse has been a Deerfield portfolio company since 2017.

V-Wave scores FDA breakthrough status on its heart failure shunt

V-Wave, Ltd., recently announced that it received the prized FDA Breakthrough Designation for its heart failure shunt. Breakthrough designation is one of the highly sought pre-approval stamps that the FDA can place on a device.

According to the FDA’s website, it is granted when the device “provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions” (than what is currently available). The program aims to provide patients and health care providers with more timely access to medical devices “by speeding up their development, assessment and review,” including prioritized review all the way through to market approval.

V-Wave’s minimally-invasive implanted interatrial shunt for the treatment of patients with severe symptomatic heart failure is designed to regulate left atrial pressure, the primary cause of breathing difficulty and hospitalization due to worsening heart failure.

“In addition to validation of the potential impact of this technology, breakthrough status will facilitate a timely regulatory review and solve a major issue with medical device investments, namely that reimbursement will effectively be secured immediately upon approval,” said Deerfielder, Andrew ElBardissi, MD, who serves on the Company’s board of directors.

The shunt is currently being evaluated in a global, randomized, controlled, double-blinded, 500 patient pivotal Investigational Device Exemption trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced left ventricular ejection fraction who

remain symptomatic despite the use of guideline directed medical and device therapies.

An ejection fraction is an important measurement of how well the heart is pumping and is used to help classify heart failure and guide treatment. In a healthy heart, the ejection fraction is 50 percent or higher – meaning that more than half of the blood that fills the ventricle is pumped out with each beat.

According to the Centers for Disease Control and Prevention, nearly 6 million adults in the United States have heart failure and about half of these individuals die within 5 years of diagnosis. Heart failure costs the nation an estimated $30.7 billion each year.

Achieving this status means that the device also met at least one of the following FDA criteria:

  1. It represents breakthrough technology;
  2. No approved or cleared alternatives exist;
  3. It offers significant advantages over existing approved or cleared alternatives; and
  4. Availability of this device is in the best interest of patients.

V-Wave, Ltd., a privately held medical device company, has been a Deerfield portfolio company since 2018.

Adapted from company news release: V-WAVE’S INTERATRIAL SHUNT RECEIVES FDA BREAKTHROUGH DEVICE DESIGNATION FOR HEART FAILURE:

https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142

https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm

Neochord

Neochord, Inc. is developing a minimally invasive device that replaces a procedure currently done with open heart surgery to reduce mitral regurgitation. Approximately 200 patients have been treated with this device in Europe (CE Mark achieved) and the company will initiate the US IDE study later this year.

InCarda Therapeutics

InCarda Therapeutics is developing a drug/device combination for in-hospital and outpatient treatment of acute atrial fibrillation. By using the pulmonary circulation to deliver drugs to the heart, lower doses and faster cardioversion are likely to occur compared to oral and intravenous therapies. The initial target market will be the in-hospital setting where most patients with atrial fibrillation currently require electrical cardioversion, an invasive and costly procedure.

Deerfield Discovers Gender Affects Treatment and Outcome in Abdominal Aortic Aneurysm

New York, NY – December 21, 2017 – Deerfield announced today the publication of “Persisting disparities between sexes in outcomes of ruptured abdominal aortic aneurysm hospitalizations” in the journal Scientific Reports. Scientific Reports is a peer-reviewed, open-access journal from Nature Research. This is one of 12 articles written by Deerfield this year that has been published in peer reviewed journals.

The article, written by Deerfield Institute’s Mark Stuntz, Céline Audibert and Zheng Su, examines the discrepancies between the sexes in outcomes of ruptured abdominal aortic aneurysms (rAAA). Deerfield showed that although the incidence and mortality for rAAA has generally improved over time for both males and females, discrepancies still exist between the male and female population. Its findings revealed that females remain at a higher risk of in-hospital death than males and are less likely to undergo rAAA repair. In fact, even if females did receive surgery, they were more likely to have fatal outcomes. This article is intended to stimulate further exploration of gender based differences in the treatment of abdominal aortic aneurysms with the goal of improving outcomes.

About Deerfield

Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy.

For more information, please visit www.deerfield.com.

Contacts

Deerfield Management Company
Karen Heidelberger, 212-551-1600
[email protected] 

The article can be found at http://www.nature.com/articles/s41598-017-18451-2