Kleiner Device Labs Receives FDA Clearance

[image] Dear Angel Insider, Alpha surgeons will begin initial trials of the KG2 device. In May 2021, the Kleiner Device Labs (KDL) team submitted their KG2 spinal fusion device to the FDA for 510(k) clearance. This clearance is required before KDL can start marketing and selling the KG2 device. And on Sept 22nd 2021, management announced the KG2 has now been granted full 510(k) clearance! For investors, it marks an important milestone towards successfully commercializing the product and marching towards a potential exit. (which is, in any medical device company’s path, what may be an eventual exit.) For example… - Vertiflex – a company that sells minimally invasive devices to treat patients with moderate degenerative lumbar spinal stenosis – [received 510(k) Clearance for their Superion® InterSpinous Spacer on May 27th, 2015.]( On May 9th, 2019 – four years later – Boston Scientific (NYSE: BSX) announced plans to acquire the company for $465m in cash, plus additional payments on commercial milestones for the following three years. The valuation was based on an expected $60 million in sales in 2019… from one product… at a 7.75x multiple at the time of acquisition! For investors who invested in their 2006 round at a $39m valuation, this represents a potential 11.9x return on invested capital (assuming no dilution). Here’s another example... - Ellipse Technologies – a MedTech company focused on implantable technologies for the treatment of a broad spectrum of spine and orthopedic applications – [received 510(k) clearance on August 24, 2011]( The technology is called the PRECICE® Intramedullary Limb Lengthening System. On February 4th, 2014,[the company received 510(k) clearance for their next generation PRECICE® 2 Intramedullary Limb Lengthening System.]( On September 30th, 2014,[the company also received 510(k) for their MAGEC (MAGnetic Expansion Control) Spinal Bracing and Distraction System.]( Then, on January 5th, 2016, NuVasive, Inc (NASDAQ: NUVA) bought the company for $380 million in cash, plus up to another $30m in additional earnouts (for $410m total)! This valuation was based on approximately $40 million in sales in 2015… from two products… at an estimated 10x multiple at the time of acquisition! For investors who invested in their 2011 round at a $15m valuation, this represents a potential 27x return on invested capital in ~5 years (assuming no dilution). - While there is no guarantee that Kleiner Device Labs will be acquired, the market comps paint a compelling picture for what is possible in the medical device market. [According to iData Research]( it’s estimated that surgeons perform 352,000 interbody fusions – which is what the KG2 would fall under – each year. The KG2 will cost ~$3,000 for a single-use device. According to KDL management... if an average surgeon performs six surgeries per month using the KG2, that would mean 72 total surgeries per year that potentially generate $216,000 in annual revenue. If we assume a 7x - 10x multiple, this means every single surgeon they acquire could potentially add $1.5m to $2.1m in total valuation! This means if Kleiner Device Labs can successfully onboard 250 surgeons, who perform a combined 18,000 procedures per year... The company could potentially generate an estimated $54 million in annual revenue and have a potential valuation of $378m - $540m! Currently, they have 10 surgeons already onboard for the alpha round of testing. However, based on early interest from surgeons regarding the KG2, KDL management is projecting they could potentially reach this sales target by the end of 2025. Not to mention, the KDL team has more follow-on products currently in development. [image] Considering an investment in Kleiner Device Labs? [If so, you can review their offering on the Equifund Crowd Funding Portal by clicking here now.]( [image] PS- in case you missed it earlier, this was [an email I sent out a few days ago]( [image]( DISCLAIMER: To more fully understand any Ragingbull.com, LLC (“RagingBull”) subscription, website, application or other service (“Services”), please review our full disclaimer located at FOR EDUCATIONAL AND INFORMATION PURPOSES ONLY; NOT INVESTMENT ADVICE. Any RagingBull Service offered is for educational and informational purposes only and should NOT be construed as a securities-related offer or solicitation, or be relied upon as personalized investment advice. RagingBull strongly recommends you consult a licensed or registered professional before making any investment decision. RESULTS PRESENTED NOT TYPICAL OR VERIFIED. RagingBull Services may contain information regarding the historical trading performance of RagingBull owners or employees, and/or testimonials of non-employees depicting profitability that are believed to be true based on the representations of the persons voluntarily providing the testimonial. However, subscribers’ trading results have NOT been tracked or verified and past performance is not necessarily indicative of future results, and the results presented in this communication are NOT TYPICAL. Actual results will vary widely given a variety of factors such as experience, skill, risk mitigation practices, market dynamics and the amount of capital deployed. Investing in securities is speculative and carries a high degree of risk; you may lose some, all, or possibly more than your original investment. RAGINGBULL IS NOT AN INVESTMENT ADVISOR OR REGISTERED BROKER. RESULTS PRESENTED NOT TYPICAL OR VERIFIED.RagingBull Services may contain information regarding the historical trading performance of RagingBull owners or employees, and/or testimonials of non-employees depicting profitability that are believed to be true based on the representations of the persons voluntarily providing the testimonial.However, subscribers’ trading results have NOT been tracked or verified and past performance is not necessarily indicative of future results, and the results presented in this communication are NOT TYPICAL. Actual results will vary widely given a variety of factors such as experience, skill, risk mitigation practices, market dynamics and the amount of capital deployed. Investing in securities is speculative and carries a high degree of risk; you may lose some, all, or possibly more than your original investment. RagingBull nor any of its owners or employees is registered as a securities broker-dealer, broker, investment advisor (IA), or IA representative with the U.S. Securities and Exchange Commission, any state securities regulatory authority, or any self-regulatory organization. Employees, owners, and other service providers of [Ragingbull.com](), LLC are paid in whole or in part by commission based on their sales of Services to subscribers. WE MAY HOLD SECURITIES DISCUSSED. RagingBull has not been paid directly or indirectly by the issuer of any security mentioned in the Services. However, [Ragingbull.com](), LLC, its owners, and its employees may purchase, sell, or hold long or short positions in securities of the companies mentioned in this communication. If you have a current active subscription with The Boardroom you will need to contact us [here]() if you want to cancel your subscription. Opting out of emails does not remove you from your service at The Boardroom. [Unsubscribe from Angel Insights Newsletter]( Click [Unsubscribe]( To Unsubscribe From All RagingBull Emails RagingBull.com, LLC 62 Calef Hwy #233 Lee, New Hampshire 03861 United States (410) 775-6138