Innovative Advances in Heart Failure Treatment by Berlin Heals
Berlin Heals Holding AG is making significant strides in the realm of heart failure therapies. The Swiss MedTech company is dedicated to developing less invasive treatments aimed at reversing heart failure, which has garnered attention in the medical community. Having completed a successful First-In-Human study in 2019, they followed up with substantial long-term results and a Randomized Controlled Trial aimed at enhancing their device's efficacy.
Novel Approach to Treatment
The new treatment methodology involves an implant that consists of two electrodes linked to an implantable generator. This generator delivers a constant direct microcurrent across the impaired heart tissue. Such a steady DC current has shown promise in reducing inflammation and remodeling the heart, leading to improved cardiac function and lessening patient symptoms, something previous studies have affirmed.
Funding for Expansion and Innovation
Recently, after securing an A1 funding round, Berlin Heals has made significant advancements in testing and developing their innovative approach. They initiated a new First-In-Man study, named the CMIC-III trial, which involves a less invasive implantation that can be performed in an outpatient setting. This shift not only suggests quicker recovery times for patients but also enables a broader range of clinicians and hospitals to access this groundbreaking therapy.
Future Prospects and Financial Backing
The latest A2 funding round is directed at completing the ongoing CMIC-III trial, prepping for future double-blind studies, and gathering essential documentation for a submission to the FDA for Investigational Device Exemption. The company's commitment to developing a game-changing device for heart failure patients is evident through their innovative approaches and persistent efforts in research and development.
John Brumfield, the Chief Executive Officer of Berlin Heals, conveyed enthusiasm about their journey, stating, "We are grateful for the continued and long-term support from our internal investors while we welcome our new investors to this exciting path forward. Over a decade ago, we embarked on our mission to revolutionize the heart failure market, and our promising results affirm the potential we anticipated. This funding fuels our momentum to bring new treatment options to millions needing support against heart failure worldwide."
Commitment to Heart Failure Solutions
Marko Bagaric, a Co-Founder and Board Member at Berlin Heals, emphasizes the company's strong vision: "From the outset, we have aimed to do more than merely mask the symptoms of heart failure. Our goal has always been to actualize the reversal and remodeling of the heart to restore it to a healthier state. The positive clinical results from our early studies have surpassed expectations. With the innovative outpatient implantation technique we’re pursuing, we aim to expand our reach to a larger patient population who can benefit from this treatment."
About Berlin Heals Holding AG
Founded in 2014, Berlin Heals Holding AG is a Swiss joint-stock company committed to transforming the standards of care in heart failure treatment. The company is currently championing the evaluation of their implantable device, known as the "C-MIC" (Cardiac Microcurrent), which is under review by CE regulatory authorities. Notably, the C-MIC system recently received a Breakthrough Device Designation, highlighting its potential, and has been accepted into the Total Product Life Cycle Advisory Program (TAP) with the FDA, underscoring the importance of its development and approval process.
Frequently Asked Questions
What is the focus of Berlin Heals Holding AG?
Berlin Heals Holding AG focuses on developing less invasive treatments to reverse heart failure, enhancing patient outcomes.
What technology does Berlin Heals use for treatment?
They utilize an implantable device that delivers microcurrents to reduce inflammation and remodel the heart.
What is the significance of the CMIC-III trial?
The CMIC-III trial aims to evaluate a less invasive implantation method for their device, allowing for faster recovery.
How will the A2 funding round impact the company?
The A2 funding will facilitate trial completion and support further FDA submissions, advancing their development efforts in heart failure treatment.
When was Berlin Heals established?
Berlin Heals Holding AG was founded in 2014 and has made considerable progress in heart failure technology since then.
