Posts Tagged afib
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on December 17, 2014
Narsi Rangachari, co-founder of InCarda Therapeutics talked about InCarda’s novel approach to delivering drugs straight to the heart.
Approximately 20 million patients a year in the US, experience one or more forms of acute cardiac conditions. Current therapies to treat acute conditions are not optimal. They are slow, have not effective presenting higher risk. Current therapies also seem to cause a great deal of patient discomfort, resulting sometimes in poor quality of life, frequent and continuing ER visits, and extended hospital stay. Cardiac conditions add a tremendous burden to the overall healthcare costs. Cardiac arrhythmias rank as number 7 among the top 10 reasons for hospitalizations. There are little to no acute interventions in treating patients with atrial arrhythmias.
Atrial Fibrillation (also called Afib or AF) is a serious but non-life threatening condition that causes irregular and often-rapid heartbeats and many a time where the patient experiences debilitating symptoms. Global prevalence of AF is over 34 million and growing, with more than 5 million Americans estimated to suffering from the disease. Oral tablets approved for chronic treatment of AF are 30-50% effective, have very slow onset and are generally not suited for acute intervention. Few of the new drugs have made it to the market and these have not proven to be safe and effective. Ablation is an expensive and invasive procedure requiring repeat procedures, require hospital stays and are often associated with serious adverse events.
InCarda’s patented technology focuses on targeting the drugs to the heart via the lungs, said Rangachari. He spoke about a variety of technologies available to deliver drugs to and through the lungs. These included portable nebulizers, dry powder aerosols and breath controlled pulmonary delivery. The benefit of inhalation in treating atrial arrhythmias is that it delivers a “first pass” to cardiac tissue, delivering a bolus of drug directly to regions of the heart where stimuli for acute atrial arrhythmias arise. This permits rapid onset, lower off-target tissue exposure of the drug and – importantly – can be self-administered by the patient. InRhythm currently under development to treat widespread symptomatic atrial arrhythmia conditions like paroxysmal atrial fibrillation (PAF) uses approved drugs in a new dosing paradigm. InCarda has developed a de-risked approach by employing well studied, first line drugs, with long histories of efficacy and safety. In addition, the Company is using validated endpoints with established clinical assays and using commercially available inhalation devices for clinical evaluation. It was a very interesting talk and was followed by Q&A.
PS – See similar article on Pearl Therapeutics http://bit.ly/NnPhwI , a tiny company that focused on inhalation drug delivery for conditions like asthma and COPD and was bought by Astra Zeneca for $1.15 Billion.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on January 19, 2013
Disclaimer – Below is my best attempt to capture highlights from company presentations. Please check details against more authentic sources, before making any financial decisions.
The overview of the conference can be found at this link – http://bit.ly/UY1Cpk . In the next few links, I will share some highlights from presentations of big pharmaceutical companies. The recent global recession with challenges pertaining to price/volume issues, healthcare reforms, more restrictive regulatory environment, medical device taxes, medical reimbursement cuts, and extreme pressure to contain costs have put a lot of pressure on the device industry. Big Pharma is slightly different. Historically the industry has enjoyed growth rates in double digits and 20% operating margins with growing demand and big profits. But times are also changing for big pharma. Many firms responded to initial challenges by investing heavily in next-generation drugs, often based on biotechnology. Though promise of biotech has not panned out as expected, there is more fat in big pharma than in device industry. Below are highlights from some medical device companies.
Medtronic – Looking at returning 50% of capital back to shareholders over next several years
President & CEO, Omar Ishrak talked about the efforts undertaken during the last 18 months to operate more effectively in the changing healthcare environment. There is tight alignment and the company has made changes in business teams, making them accountable for growth. Three major US markets, ICDs, Core Spine, and Pacing, have started to stabilize. Additionally, Medtronic is focusing on multiple high growth platforms, including advanced energy, afib, glucose monitoring, deep brain stimulation and so on. As opposed to 10% return in 2012, for several coming years, Medtronic is looking at 20% revenue growth, for several years to come, said Ishrak. Medtronic is expecting to recoup $25B, in next 5 years, mostly from outside the US and is expecting to continue 50% rate of return to the shareholders, that is, $12.5B return to shareholders, over next 5 years.
Medtronic will also focus on generating more cash in the US, through increasing demand, visibility of supply chain, minimizing idle inventory, optimizing supply chain, reducing operating expenses, and finally repatriating cash from outside the US, if the tax policy becomes fair, said Ishrak. With increasing globalization, there will be continued focus on premium segments in emerging markets, particularly India and China. Additionally, Medtronic will also focus on value segment and underserved segments through creating infrastructure capability and then aim to bring the innovation back and disrupt developed markets. Medtronic is quickly adapting to the changing healthcare landscape, and moving from old fee for service model to new pay for value model, said Ishrak.
Stryker – Continued focus on M&A, share buy backs, and cash flow generation
Stryker CEO, Kevin Lobo said the company is focused on innovation, has a robust balance sheet and will continue strong cash flow generation. In 2012, the total revenue was $8.7B, up 4% from previous year and adjusted earnings per share increased 9%. Stryker has a very diversified market focus, with no single market representing more than 16%, said Lobo. US represents 2/3rd of total Stryker sales or 65% of the business. 29% is in Europe and the rest 6% is in emerging markets and Stryker aims to grow in these markets. Although 2012 was a quieter year from acquisition standpoint, Stryker will continue to focus on M&A and will continue to buy back shares and is looking at strong steady cash flow generation, said Lobo.
Hansen Medical – Maintains Leadership in Intravascular Robotics with Launch of New Products
CEO, Bruce Barclay asserted that Hansen continues to be a global leader in intravascular robotics and sees it as a platform technology in EP (electrophysiology) and vascular space. Hansen also has a strong pipeline and is developing a full suite of catheters to go with its technology. Hansen catheters and other flexible robotics have largely known to be used in catheter based interventional medical procedures, particularly for treatment of irregular heart arrhythmias.
In 2012, Hansen launched Magellan (TM) Robotic System in the US that allows Hansen to enter much larger vascular market, on account of greater precision and predictability of the distal tip control. Hansen has also launched some new products in the EP space. Artisan Extend catheter was approved in the US, last year and just got approval in the Europe. Improved procedure predictability of Hansen products offers an opportunity to hospitals for lowering cost and incremental patient turnaround. Additionally, it is vastly helpful to the physician, who can sit comfortably at a console, does not have to wear lead coat, is away from the radiation field, and has lower risk of orthopedic injuries. Therefore, this is a good ROI model.
Hansen has had five consecutive quarters of procedure growth on the robotic side and is now approaching 10,000 cases. Hansen had 14 new patents issued in 2012 and new transaction with Intuitive Surgical added $30M to the balance sheet. Hansen focuses on early adopters of new technology and on training them well, in this $2B+ medical robotics market, said Barclay.
St. Jude – Poised to deal with challenges and deliver long term growth
Daniel Starks, President, Chairman and CEO of St. Jude reported that preliminary sales for Q4, 2012 were as expected, at approximately $ 1.372 billion. The company initiated $1B share repurchase program, at the end of 2012, and expects a favorable impact from this in 2013.
Globally ICD market declined 3%, in 2012. St. Jude’s ICD market share has been stable, with some decline offset by CRT-D and replacement segments. Most recent data also allays previous market concern about reliability and safety of Durata line of (HV) high voltage leads. Durata lead survival at 5 years is shown to be 98.7% and compares favorably with MDT line of HV leads. FDA inspection of SymarCA facility generated form 483. None of the observations were pertaining to performance of Durata HV leads and all will be remedied with urgency, assured Starks. HV lead revenue comprises of less than 4% of STJ global sales.
Various cost saving initiatives have generated more than $100 million in cost reductions in 2012 and are expected to generate more than $100 million in additional cost savings in 2013. These cost savings plus $1B share repurchase will enable STJ to fund incremental R&D investments, expand market share development activities, and absorb the US medical device excise tax. While sales growth is expected to remain challenging due to macro-economic factors, STJ is well position to deal with the headwinds and deliver long term growth. Some of the growth drivers in 2013 will be, MediGuide non-fluoroscopic catheter tracking technology with STJ AF platform, LAA and PFO closure to reduce risk of stroke, STJ’s FFR and OCT product lines, STJ next generation EnligHTN renal denervation technology, TAVR and Trifecta tissue valve product lines, and the recovery of STJ neuromodulation franchise, said Starks.
Glaukos – Private Opthalmic Medical Device Company for management of Glaucoma
Glaukos is a private opthalmic medical device company. Thomas Burns, CEO and President of the company shared about Glaukos for management of glaucoma. Glaucoma is a long lasting, permanent condition that does not cause immediate blindness but causes dark patches or areas of blindness. High pressure caused by excessive fluid produced by the eye, can damage the optic nerve and lead to glaucoma. Glaukos technology is primarily an infinitesimal titanium stent, iStent, that can be implanted in the eye to drain fluid and thus reduce the pressure that leads to glaucoma. The iStent is the smallest medical device ever approved the FDA and is placed in the eye during cataract surgery. It is small enough that the patient will not see or feel it after surgery and post surgery, it continues to work to help reduce eye pressure. The 2nd generation G2 device is smaller than the first generation device, and can be loaded into a needle and injected at a predictable rate. Glaukos suprachoroidal stent model G3 device is currently in phase 3 trials.
All products are CE marked and there is great progress in reimbursement, said Burns. The current number of about 70 million patients in the US is expected to reach 80 M by 2020. CPT codes are established and currently 4100 stents are implanted to date.