Apollo Endosurgery Inc (APEN) is a biotech company, focusing on the product design, establishment, and commercialization of medical-related machinery. The company’s target market includes medicinal service providers; and clinics, outpatient surgical centers, bio labs, and doctors in the US, Brazil, Australia, and other European countries.
Current Apollo Endosurgery Inc Stock condition
Apollo Endosurgery Inc (APEN) stock had an increment of 7.06% while the S&P 500 company decreased -0.31%. APEN has gained $0.37 from the previous closing price of $5.24 with a volume of 111,743 shares. Compared to last year the S&P 500 is higher by 16.45% while APEN has gained 75.86%. APEN lost -$1.24 per share over the last 12 months.
FDA Approval for Breakthrough Design Designation of Orbera
The company has soared on Monday’s premarket by 35% due to receiving news of an FDA breakthrough. This breakthrough in the biotech company specifically happened in designating approval for a treatment device called OrberaIngastric Balloon (OIB) that is used for treating patients that have an unhealthy range of BMI between the range of 30-40 kg/m2 and have liver fibrosis. This OIB administers noncirrhotic, nonalcoholic steatohepatitis (NASH).
Orbera is essentially a one-of-a-kind non-invasive, non-surgical weight loss alternate solution designed for adult patients that have life-threatening obesity; for whom the exercise, diet, and medicinal intervention have not worked and neither has the patient been approved for surgery.
This FDA approval for design designation will now allow for the provision by the FDA of intensive guidance for the procurement and development through the assigning of high-ranking senior agency personnel. Furthermore, OIB will also be assigned a case manager, as well as the reviewing of the marketing applications, will get a priority-based status. This approval is akin to Breakthrough Therapy Status.
Why is this significant
There are no approvals by the Food and Drug Administration (FDA) for treatment of non-alcoholic steatohepatitis (NASH) as such before. We know obesity is one of the leading causes of death in the USA with obesity-caused conditions like heart diseases, heart-stroke, type 2 diabetes, and certain cancers. However, NASH also causes an increase in morbidity rate through liver-related diseases and is one of the top 3 reasons for a liver transplant.
The adult population in the USA that has a NASH within a range of 30-40 kg/m2 consists of 10 million people. Previously the only non-invasive and non-incision treatment solution was a Total Body Weight Loss (TBWL) recommendation. Now with Apollo’s Orbera, it will effectively reduce the TBWL to a 7-10% range. This is backed up by extensive study and experiment where weight loss of 7-10% was observed in the 6-12 months period.
Should you invest in Apollo Stocks?
Apollo product sales increased 25% to $3.8 million for the first quarter of 2020. Outside the US, ESS product sales decreased 12% (8% in constant currency) to $3.1 million for the first quarter of 2020 primarily due to the Coronavirus pandemic, however, in the last quarter, the sales jumped up and even increased 0.2% compared to 2019 fourth quarter.
The US Investing research analysis has issued “buy,” “hold,” and “sell” ratings for Apollo Endosurgery in the last year. There is currently a 1 buy rating for the stock. The agreement between US shareholding research analysts is that apollo stocks may bring incredible capital gain in the future.