Neuromodulation — where an external or implanted pulse generator sends mild electric pulses to targeted nerves to achieve a certain therapeutic effect — has been gaining ground in recent years with new applications.
Especially in the area of chronic pain, where drugs have been the preferred therapy modality, people are looking into neuromodulation given the opioid crisis in the nation. A market research report published in October 2015 projected that the devices pain management market, will grow to $3.5 billion in 2020, up from $3.1 million last year.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Johnson & Johnson doesn’t have an internal neuromodulation program, confirmed a spokeswoman, but the company’s venture arm — Johnson & Johnson Development Corp. (JJDC) — has been pretty active in the neuromodulation space for several years.
The news of the latest investment came earlier this month when JJDC took the lead investor role in a $93 million funding round in Minneapolis-based CVRx. Last November, CVRx received FDA’s Expedited Access Pathway status for its Phase III randomized, controlled clinical, pivotal trial, Baroreflex Activation Therapy for Heart Failure (BeAT-HF). That trial will test the safety and effectiveness of Barostim Neo in congestive heart failure patients. The Expedited Access Pathway program is FDA’s fast-track method of approving novel, innovative devices and is intended to encourage innovation.
Through a spokeswoman, Michael Chuisano, vice president of venture investments and chief operating officer of Johnson & Johnson Innovation—JJDC answered some questions about the CVRx investment. He also addressed the corporation’s interest in neuromodulation. Here is a slightly edited version of Chuisano responses:
MedCity: CVRx has had trouble getting their device approved in the U.S. What gave you the confidence to lead this round?
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Chuisano: The device CVRx applied for approval in the U.S. was the RHEOS device and it was for the hypertension indication and this was back in 2010. The company’s pivotal trial failed to meet endpoints, but demonstrated efficacy and long term safety.
The newest CVRx device, Barostim Neo, a smaller device with only one lead, is the product currently approved under CE Mark in Europe and part of the recent and active heart failure trials. The Barostim technology has been used in over a 1,000 implants has shown efficacy in both hypertension and heart failure applications, and has a large patent estate surrounding the technology.
These early trials and long term data from hypertension patients provided support for exploring heart failure as a possible indication.
A recently completed phase 2 Heart Failure Trial (Hope4HF), whose data was published in 2015, confirmed the findings of the early studies. The recent multicenter Hope4HF trial demonstrated positive results that were published and has provided a basis for their Pivotal Registration Trial in the U.S. for BeAT-HF.
This data was used in the application for the accelerated EAP review at the FDA. Should the BeAT-HF trial be successful, this may provide a significant new option for physicians to treat Class III heart failure, along with their hypertension product.
MedCity: How much money did J&J invest in this round? How much has it invested in the past?
Chuisano: Our initial investment in the CVRx was in 2007. We are not disclosing how much we have invested in the company. [MedCity: Back in 2013, Johnson & Johnson Innovation and NEA were co-leads in a $29.6 million investment round.]
MedCity: Neuromodulation is growing in terms of the number of applications we are seeing. Why is this category important to J&J?
Chuisano: We believe that neuromodulation technologies have the potential to be applied across many large markets with significant unmet needs that align with J&J’s strategic areas of interest. These include other neuromodulation areas such but not limited to: epilepsy, pain, Parkinson’s disease, sleep apnea, as well as many other chronic disease and conditions not well managed by drugs or that are drug resistant.
MedCity: Can you talk about what JJDC has in its current device portfolio under neuromodulation?
JJDC has invested in eight different companies working in the neuromodulation space, and is currently invested in seven of which two of these have completed successful IPO’s.
Chusiano did not identify the companies but one which went public and lists JJDC as a shareholder is Nevro. The Redwood City, California, company has developed the HF10 neuromodulation system. Data from the company’s trials have been published in the Journal of American Society of Anesthesiologists show that it is superior to traditional spinal cord stimulation systems.
Photo: Flickr user Tax Credits
