In The NEWS

CLAIRE WALLACE • TUE, MAY 14TH, 2024 

Leadership teams play a crucial role in running the top orthopedic and spine device companies nationwide. 

From CEOs, to CFOs, to supply chain managers, these leaders manage finance, global logistics, business development and more. 

Here are the supply chain leaders of three of the top spine device companies worldwide: 

Kleiner Device Labs (Incline Village, Nev.): Jeff Barclay leads supply chain operations at Kleiner Device Labs. He has extensive experience with planning and procurement, from start-ups to multinational corporations. He is known for building and leading high-performing teams to drive cost reduction alongside service improvement, as well as implementing process improvement.

Medtronic (Dublin, Ireland): George Smith joined Medtronic in 2021 as executive vice president of global operations and supply chain. He is responsible for the performance and integration of all aspects of the company’s operations including manufacturing, supply chain, supply management, operational excellence and transformation, enterprise risk and facilities and operations quality. He was most recently a supply chain executive at Walmart. 

Zimmer Biomet (Warsaw, Ind.): James Rachal joined Zimmer Biomet in 2019 as its director of North American logistics. In 2020, he was named senior director of global logistics, leading the company's supply chain operations. He oversees the distribution and transportation of orthopedic products to customers worldwide, ensuring compliance, efficiency and customer satisfaction.

ELIZABETH HOFHEINZ, M.P.H., M.ED. • WED, MARCH 20TH, 2024 

Incline Village, Nevada-based Kleiner Device Labs (KDL) has announced that the first 50 cases are now in the books for their novel KG®2 Surge® flow-thru interbody system.

The official announcement came at the Southern Neurosurgical Society’s 2024 annual conference in Orlando, Florida. According to the company, the KG 2 Surge system reduces risks from poor/insufficient graft volume and placement, surgical site infection (SSI), collateral tissue damage due to multiple instrument passes, and from lengthy OR time.

According to Kleiner Labs the first 50 cases with the new KG 2 Surge used an average of 10ml of bone graft delivered per disc space and an average of eight minutes total elapsed time for trial, cage placement, grafting and release of the implant.

"Posterior approach spine fusion has a number of inherent risks to patients’ health and successful outcomes, as well as significant frustrations for surgeons, and those became the key objectives of our re-engineering a complete interbody system,” said Jeff Kleiner, M.D., KDL founder and CEO.

“One thing that stands out about our development process is the feedback we got from surgeons who tried it in our first cadaver verification/validation lab with four active surgeons in April of 2022,” added Dr. Kleiner.

“Surgeons were given a chance to trial the KG2, both in open and MIS procedures. The feedback from that lab was incredibly gratifying to me and the engineering team, and helpful in understanding how best to introduce KG2 to surgeons in the market. All surgeons were delighted and amazed at how easily the system worked, how much graft they could get into the disc space and how simple and time efficient it was.”

“We had set out to address one of the key failure factors in spinal fusion surgery—getting adequate graft into the prepared disc space to promote a biologically based fusion. Improving the volume of delivered graft was anticipated to improve the fusion failure rate, which has historically averaged 1-in-4.”

“We also designed our proprietary flow-thru technology, complete system and single patient use set approach to address a number of challenges faced by most surgeons: unnecessary steps, cross-contamination, and dependency on central supply.”

According to Dr. Kleiner, here were some of the comments surgeons had about the KG2 system:

• “Solved the fussiest part of the spinal fusion surgical process.”
• “Eliminated the fiddle factor.”
• “It takes the guesswork out.”
• “More graft and less tedious grafting.”

“One of the most captivating observations that was made from analysis of the KG 2 initial launch data was that nine different surgeons were able to apply an average of 10ml of graft material to the prepared disc space and this was independent of the graft flowability. The KG 2 system demonstrated that it was agnostic to graft type or consistency.”

“Another interesting observation from the KG 2 initial launch data was that the combination of multiple steps into a single surgical pass saved so much time. We had anticipated that it would be a time saver, but the fact that determining the size of the implant, inserting the KG 2, grafting the disc space, and releasing the implant would only take an average of eight minutes was remarkable.”

Making the Posterior Approach Attractive Again

As for how this may shift surgeons’ thinking on the posterior approach, Dr. Kleiner told OTW, “I think the KG 2 system will reawaken the surgeon’s interest in posterior approaches because it simplifies and standardizes the tedious and potentially injurious process of grafting the disc space during interbody procedures.”

“The pre-assembled and pre-sterilized system reduces the training necessary for the operating room team and virtually eliminates the cross-contamination of surgical instruments because there is no touching of the implant necessary before its insertion, nor is there pre- or post-packing of graft material.”

“Posterior operations provide a great deal of benefit for the patient because they provide a familiar approach for most surgeons and allow a reliable and direct decompression of neural elements. One of the challenges of the posterior fusion was reliably grafting the disc space during an interbody posterior approach. The resultant ‘graft insecurity’ was especially evident in minimally invasive procedures and led to the dependence on chemical adjuvants in many procedures. The KG 2 system is graft agnostic and allows for sufficient graft volume to maximize the quality and volume of graft material applied. This process is independent of surgical approach and technique and allows for less expensive alternatives for grafting the disc space.”

INCLINE VILLAGE, Nev., Feb. 29, 2024 

Kleiner Device Labs (KDL) today announced that an e-Poster has been accepted for the Southern Neurosurgical Society's 2024 annual conference beginning on March 7 in Orlando. The e-Poster (#156) highlights research results of new innovations in lumbar spinal implant and grafting technologies to reduce risks from poor/insufficient graft volume and placement, surgical site infection (SSI), collateral tissue damage due to multiple instrument passes, and from extended OR time.

"Posterior approach spine fusion has a number of inherent risks to patients' health and successful outcomes, as well as significant frustrations for surgeons, and those became the key objectives of our re-engineering a complete interbody system," said Jeff Kleiner, MD, founder and CEO of KDL.

Dr. Blake Burkert, of NeuroSpine Group, Eugene, Oregon, noted, "I share those concerns and want to minimize risks in my own OR. Utilizing the new system over the past year has proven to be an effective answer for my PLIF and TLIF procedures and has transformed my thinking on the posterior approach to treating spine conditions."

The company will attend the meeting and looks forward to demonstrating the new KG®2 Surge® flow-thru interbody system to surgeons. The first 50 cases with the new KG 2 Surge demonstrated an average of 10ml of bone graft delivered per disc space and an average of 8 minutes total elapsed time for trial, cage placement, grafting and release of the implant.

The e-Poster presentation will be available at the meting and afterwards on the company's web site.

For KG2 videos and information, please go to the company's web site.

by Carly Behm - Friday, February 23rd, 2024

Spine devicemakers took important steps forward in innovation in 2023, and many are gearing up for exciting plans in the months ahead.

Here are 10 spine device companies to watch in 2024 in alphabetical order:

Accelus (Palm Beach Gardens, Fla.): In January, Accelus earned a $20 million debt facility that will help support the company's focus on its Adaptive Geometry for th FlareHawk interbody fusion system....

Alphatec (Carlsbad, Calif.): Alphatec has a new spine robot under its belt after acquiring the navigation system from Fusion Robotics, a subsidiary of Accelus....

Augmedics (Chicago): Augmedics' augmented reality spine headset, Xvision, continues to gain traction...

Globus Medical (Audubon, Pa.): Globus Medical merged with NuVasive in September and is entering its first full year as a combined company....

Johnson & Johnson — DePuy Synthes (West Chester, Pa.): DePuy Synthes is restructuring its orthopedic segments....

Kleiner Device Labs (Incline Village, Nev.): Kleiner Device Labs has seen progress with its KG2 Surge flow-thru interbody system in 2023. The first 50 cases were completed by August, and later in October the device earned a U.S. patent.

Medtronic (Dublin, Ireland): And in February Medtronic named its first chief sustainability officer. The new leader, Raman Venkatesh, will lead the development and execution of Medtronic's environmental sustainability strategy....

Orthofix (Lewisville, Texas): Orthofix merged with SeaSpine in January 2023....

Stryker (Kalamazoo, Mich.): Stryker finished 2023 with fourth quarter and full-year revenue gains....

Xtant Medical (Belgrade, Mont.): Xtant Medical bolstered its portfolio in 2023 after acquiring the now bankrupt Surgalign's hardware and biologics businesses in an auction....

 ROBIN YOUNG • FRI, OCTOBER 13TH, 2023 

The U.S. patent office has just awarded patent # US20230255791A1 for a novel spine fusion system which, after the first 50 cases, took surgeons an average of only 8 minutes to trial, implant, graft and release the lumbar interbody device with the KG™2 Surge system, and that both the mean and median volume of graft delivered was 10ml.

The implant system, brand named KG™2 Surge system is manufactured by Nevada-based Kleiner Device Labs.

Founder and CEO Jeff Kleiner, M.D. said, “We set out from the beginning to create answers for surgeons to maximize spinal fusion bone graft delivery and solve many of the most frustrating parts of spinal fusion procedures that negatively impact both the patient and the surgeon.”

“The technology that we developed with the KG™2 Surge system simplifies the post-insertion delivery of a wide range of graft materials through the interbody and into the surrounding disc space,” added CTO Alan Burkholder. “Surgeons have successfully delivered milled local autograft, cortical cancellous chips, long-fiber allografts, and DBM putties.”

Kleiner’s design is the marriage of a rectangular inserter tube with a 3-D printed titanium interbody with a large matching opening and a bifurcated ramp that distributes the graft bilaterally. According to the company, that unique design allows surgeons to fill both the cage and the surrounding disc space.

The KG™2 Surge flow-thru interbody system was developed by Kleiner to maximize bone graft delivery to the prepared intervertebral disc space, and thereby streamline implant placement, positioning, and integration in the graft matrix.

Kleiner is offering a summary of the first 50 case results if you reach out to the company and ask for it.

by Julie A. Vetalice on February 08, 2023

In the first dozen live-patient lumbar spinal fusion cases performed with the new KG2 Surge flow-thru interbody system, Kleiner Device Labs found that surgeons were able to deliver an average of 12cc of bone graft into the prepared disc spaces.

Axial and coronal CT images from procedures.

The axial and coronal CT images above show disc space fill surrounding and incorporating the implant with cortical-cancellous bone in a recent case. The KG2 Surge’s pre-assembled cannula/implant is designed to maximize graft delivery, while making the process of interbody grafting dramatically easier and performed as a single surgical pass.

The first case with the system was performed in August 2022.

ROBIN YOUNG • THU, AUGUST 24TH, 2023 

A novel bone graft delivery system, which addresses the three main shortcomings of the typical bone grafting process in spine fusion surgery:

• Lack of meticulous disc space preparation
• Insufficient quantities bone graft
• Sub-par quality of bone graft.

“Overall, I think surgeons have lost track of the importance of meticulous disc space preparation and abundant, quality bone graft delivery and packing into the disc space well enough to achieve high fusion rates,” said surgeon Jeffrey Dick, M.D., of Twin Cities Orthopedics.

Incline Village, Nevada company, Kleiner Device Labs, invented and brought to market a truly novel device to address these three issues efficiently and effectively.

The device, KG™2 Surge®flow-thru interbody system has just reached its 50-case milestone.

“One of the best things about the KG2 is the ease with which one can deliver abundant bone graft through the tube and how tightly you can pack it compared to conventional techniques,” said Dr. Dick to OTW.

According to Kleiner Labs Founder and CEO Jeff Kleiner, M.D., “The new KG2 Surge was developed with the objectives of maximizing bone graft delivery to the prepared intervertebral disc space, and streamlining implant placement, positioning, and integration in the graft matrix.”

“The first fifty cases,” added Kleiner, “demonstrated excellent achievement of those objectives. We will next be moving to broader commercial availability, expanding our network of distributors and independent representatives.”

Another KG2 user, neurosurgeon Catherine Gallo, M.D., of Two Rivers Surgical Center in Eugene, Oregon, said, “I can tell that the KG2 is a very well-thought-out cage design. Somebody put some real thought into this. It is very user-friendly.”

Finally, orthopedic spine surgeon Blake Burkert, M.D., of NeuroSpine in Eugene, Oregon was pleased enough with his experience to say, “I will change my approach and do more PLIFs because the KG2 system is so easy to use and the graft volume is impressive. Love this cage system.”

The KG2 Surge flow-thru interbody system is a single-patient-use bone graft delivery tool coupled with a 3D-printed titanium I-Beam fusion implant.

The implant has no lateral walls and serves as a conduit for unimpeded flow of a broad spectrum of bone graft materials through the pre-attached, rectangular insertion tool. The rectangular cannula maximizes the cross-sectional area available for graft material flow and eliminates the challenge of trying to apply bone graft after cage insertion.

Since the system comes pre-assembled and sterilized in a single use tray, there is minimal scrub tech training and no implant tray re-processing/sterilization—an ideal system for an ASC or hospital. The KG2 system allows for a single insertion process to take the place of the multi-step, multi-instrument pass practice. The surgical procedure with KG2 Surge spares contusion of delicate nerve tissue and reduces the risk of surgical site infection.

by Carly Behm - Wednesday, May 24th, 2023 -  Spinal Tech 

Here are 35 spine and orthopedic medtech companies to follow in 2023.

Companies are listed in alphabetical order.

...

Kleiner Device Labs. Kleiner Device Labs was founded by Jeffrey Kleiner, MD, in 2013. The company developed the KG1 bidirectional graft delivery system and the KG2 Surge interbody implant.

Life Spine. Life Spine focuses on minimally invasive spine surgery. Its ProLift cage has been found to increase anterior disc height by 85 percent in TLIF procedures compared to static cages.

Medtronic. Medtronic is known for its spine robot, Mazor X Stealth Edition. Its other spine products include the Prestige LP cervical disc and Vanta spinal cord stimulator.

Nexus Spine. Nexus Spine has four key spine portfolios: PressON, Tranquil, Stable and PreView/Active. 

Globus Medical. Globus Medical is known for its Excelsius GPS and Excelsius3D spine navigation and imaging systems. The company is set to buy spine devicemaker NuVasive.  

Orthofix. Orthofix merged with SeaSpine in January. The company distributes products in 68 countries, and its portfolio includes the M6-C artificial disc, Legacy demineralized bone matrix and Firebird sacroiliac joint fusion system.

...

Claire Wallace - Monday, December 12th, 2022 

In February, Becker's published a list of 23 spine device companies to watch in 2022. Here is what they have been up to this year: 

15. Kleiner Device Labs (Incline Village, Nev.): Kleiner Device Labs debuted its new KG 2 Surge flow-through interbody system in 2022. Anders Cohen, DO, performed the first case with the device. Kleiner also received its 23rd patent in 2022. It made plans to break into the spinal fusion market, which is currently valued at $14 billion. 

by Julie A. Vetalice on Aug 02, 2022  

9. Kleiner Device Labs | Incline Village, Nevada, US | Founded: 2013

• Raised a total of $6.2 million to date in pre-seed and seed funding over four rounds.
• In 2018, the company introduced KG 1, a disposable single-use bone graft delivery tool for spinal procedures. The KG 2 Surge Flow-Thru interbody followed with initial launch in 2022; the device is designed to maximize total bone graft delivery volume and better distribute graft bilaterally into the intervertebral disc space.
• Surgeon-founded, and leadership brings experience from roles at Aegis Spine, Biomet, Cayenne Medical, Lanx, Moximed, SI-BONE, Vertiflex, Zimmer Biomet.

 18th August 2022

Kleiner Device Labs has announced that its new KG2 Surge flow-thru interbody system was used in its first surgical procedure. Anders Cohen performed a single-level transforaminal lumbar interbody fusion (TLIF), fusing L5-S1 at The Brooklyn Hospital Center (New York, US) on 19 July 2022.

Utilizing the new device, bone graft delivered through the KG2 conduit was more than three times the volume of the void of the collapsed disk space, say the company.

“I was honored to perform the inaugural KG2 Surge spinal fusion procedure,” said Cohen. “The system worked flawlessly, allowing precision placement of the interbody cage and fusion graft in a seamless sequential manner. The integrated fusion delivery system enabled a quick, maximum delivery of the graft material to the re-expanded disc space.

“The system is intuitive and reduces the number of steps usually needed to perform this procedure. There is minimal learning curve for the physician and our team.”

According to a company press release, the KG2 Surge flow-thru interbody system is a single-patient-use bone graft delivery tool coupled with a 3D-printed titanium I-Beam fusion implant. The implant has no lateral walls and serves as a conduit for unimpeded flow of a broad spectrum of bone graft materials through the pre-attached, rectangular insertion tool.

The rectangular cannula maximizes the cross-sectional area available for graft material flow and eliminates the challenge of trying to apply bone graft after cage insertion. Since the system comes pre-assembled and sterilized in a single use tray, there is minimal scrub tech training and no implant tray re-processing/sterilization—an ideal system for an ambulatory surgery center or hospital, add Kleiner Device Labs.

Also, the implant is directly inserted—it is not touched or pre-packed. The KG2 system allows for a single insertion process to take the place of the multi-step, multi-instrument pass practice that is typical of current spinal fusion procedures. The surgical procedure with KG2 Surge spares contusion of delicate nerve tissue and reduces the risk of surgical site infection. Because the system comes pre-sterilized and pre-assembled, it also eliminates the back table ‘fiddle factor’.

Carly Behm  - Updated Monday, August 1st, 2022 

Anders Cohen, DO, performed the first cast with Kleiner Device Labs' KG 2 Surge flow-through interbody system.

The case, a single-level transforaminal lumbar interbody fusion, was completed July 19 at The Brooklyn Hospital Center in New York City, according to an Aug. 1 news release. 

The device is a single-use bone graft delivery tool combined with a titanium fusion implant. It comes with instruments in a single tray and is designed for efficiency.

"The system worked flawlessly, allowing precision placement of the interbody cage and fusion graft in a seamless sequential manner," Dr. Cohen said in the release. 

"The integrated fusion delivery system enabled a quick, maximum delivery of the graft material to the re-expanded disc space. The system is intuitive and reduces the number of steps usually needed to perform this procedure. There is a minimal learning curve for the physician and our team."

Chris J. Stewart  August 1, 2022 

INCLINE VILLAGE, Nev., Aug. 1, 2022 /PRNewswire/ — Kleiner Device Labs today announced that its new KG™2 Surge™ flow-thru interbody system was used in its first surgical procedure. Dr. Anders Cohen performed a single-level TLIF, fusing L5-S1 at The Brooklyn Hospital Center on July 19, 2022. Utilizing the new device, bone graft delivered through the KG 2 conduit was more than three times the volume of the void of the collapsed disk space.

Noted Dr. Cohen post-surgery, “I was honored to perform the inaugural KG 2 Surge spinal fusion procedure. The system worked flawlessly, allowing precision placement of the interbody cage and fusion graft in a seamless sequential manner. The integrated fusion delivery system enabled a quick, maximum delivery of the graft material to the re-expanded disc space. The system is intuitive and reduces the number of steps usually needed to perform this procedure. There is minimal learning curve for the physician and our team.”

The KG2 Surge flow-thru interbody system is a single-patient-use bone graft delivery tool coupled with a 3D-printed titanium I-Beam fusion implant. The implant has no lateral walls and serves as a conduit for unimpeded flow of a broad spectrum of bone graft materials through the pre-attached, rectangular insertion tool. The rectangular cannula maximizes the cross-sectional area available for graft material flow and eliminates the challenge of trying to apply bone graft after cage insertion. Since the system comes pre-assembled and sterilized in a single use tray, there is minimal scrub tech training and no implant tray re-processing/sterilization — an ideal system for an ASC or hospital. Also, the implant is directly inserted—it is not touched or pre-packed. The KG2 system allows for a single insertion process to take the place of the multi-step, multi-instrument pass practice that is typical of current spinal fusion procedures. The surgical procedure with KG2 Surge spares contusion of delicate nerve tissue and reduces the risk of surgical site infection. Because the system comes pre-sterilized and pre-assembled, it also eliminates the back table “fiddle factor.”

For KG2 videos, technical specifications, instructions for use, or clinical efficacy information, please go to the company’s web site.

About Kleiner Device Labs
Kleiner Device Labs is creating new instruments and devices to advance minimally invasive spine surgery and improve outcomes and costs. Kleiner Device Labs is headquartered in Incline Village, Nevada. 

About Spine Surgery at The Brooklyn Hospital Center
The Division of Neurosurgery is one of the hospital’s centers of excellence. Led by Dr. Anders Cohen, a nationally recognized expert in minimally invasive spine surgery, the Division offers preventive care, rehabilitation, medical care and effective surgical procedures for multiple conditions of the spine and brain. For more information or to make an appointment, please call 718-250-8103 or visit tbh.org/BrooklynSpine.

Provided by PR Newswire Jun 16, 2022 12:50 PM CST 

Kleiner Device Labs (KDL) today announced that it will host a meeting room at McKinsey & Company's Early Stage Investor Conference on the morning of Wednesday, June 22 as part of the event's HealthTech track. Investors interested in talking with KDL may find more information and registration at McKinsey's conference web site here. 

"We are excited to participate in McKinsey & Company's conference to meet prospective investors for future funding opportunities," said Kleiner Device Labs founder and CEO, Jeff Kleiner MD.

KDL is in the midst of launching its next product, the KG2TM SurgeTM flow-thru interbody system, which employs the company's proprietary flow-thru technology to streamline the implant delivery, positioning and grafting processes for TLIF and PLIF spinal fusion procedures. This brings important outcome and cost improvements to spinal fusion surgeries.

For KG2 videos, technical specifications, instructions for use, or clinical efficacy information, please go to the company's web site.

Friday June 3rd

Kleiner Device Labs, based in Incline Village, Nevada, has been honored with the 2022 Medical Design Excellence Awards (Implant and Tissue-Replacement Products category) for its new KG2 Surge flow-thru interbody system.

Medical Design Excellence Awards are geared toward “life-saving innovations and remarkable technological advancements. The Medical Design Excellence Awards are determined each year by an independent panel—clinicians, engineers and designers—to select finalists as well as winners in each of 10 product categories.”

“We are proud to earn this recognition of the many years of work and innovation that have gone into developing the company’s unique flow-thru technology that is key to the new KG2 interbody system and our future product pipeline,” said Jeff Kleiner, M.D., founder and CEO of Kleiner Device Labs.

Delving into the maximizing of total bone graft delivery volume, Dr. Kleiner told OTW, “There are a couple of vital steps necessary to maximize bone graft delivery volume. First of all, attention must be directed to preparing the disc space. As much disc material as possible must be removed to create room for the bone graft. Next, using the appropriate graft delivery device is key to filling the entire space.”

“Conventional, round, end-dispensing cannulas apply the graft directly in the path of the device, fill from the bottom up, and do not distribute the graft to either side of the device; incomplete filling of the prepared area is the result.”

“A bi-portal graft extrusion system with an internal ramp within the cannula or implant is unique to the KG system and this works to direct the graft to either side of the device, allowing complete, side-to-side filling of the disc space.”

Regarding the improved distribution of graft bilaterally into the intervertebral disc space, he added, “The KG system is specifically designed to maximize the volume of graft delivered by having a ramp within the cannula or implant that allows a directed, bi-portal exit of graft material into the prepared disc space.”

“The graft naturally takes the path of least resistance and completely fills the disc space on either side of the apparatus. The interbody implant serves as a conduit through which graft material flows into the prepared disc space in the optimal distracted position.”

WILMINGTON, Del. • May 19, 2022 • PRNewswire

Equifund (https://equifund.com), a private market investment platform that delivers vetted, early-stage investment opportunities to the public, announces it successfully oversubscribed a Reg-CF offering for Kleiner Device Labs. The total amount raised was $1.07 million. 

"We're very proud to have oversubscribed another Reg-CF offering, this time for Kleiner Device Labs," said Equifund CEO Jordan Gillissie. "Our commitment to providing investors with access to unique, early-stage investment opportunities they can't find anywhere else means we are very selective with the companies that get listed on our platform. The success of KDL's offering is proof that investors appreciate our in-depth selection process, and we congratulate Dr. Jeff Kleiner and his team on their raise."

Each year more than 266 million people are diagnosed with some form of degenerative spine disease. For many, the only treatment option is spinal fusion surgery. 

Kleiner Device Labs has developed two of the primary types of surgical implants and instrumentation available for use in the spine. It holds 23 U.S. patents (32 worldwide) and recently won a bronze medal at the 2022 Medical Design Excellence Awards.

"Our experience working with Equifund has been fantastic," said Dr. Jeff Kleiner, Founder and CEO of Kleiner Device Labs. "The success of this offering has enabled us to make significant corporate advancements.  We received FDA Clearance for our new KG™2 device, arranged an initial Alpha launch for this new technology with a select group of surgeons, and are planning for a nationwide rollout shortly thereafter. We want to thank Equifund for all their efforts during this past offering, and we would not hesitate to work with them again on a future capital raise." 

Equifund connects both accredited and unaccredited investors with early-stage investment opportunities in private companies operating across a variety of industries including fintech, biotech, consumer services, and natural resources. 

For more information about how to invest in private market opportunities or raise capital from Equifund, please visit: https://equifund.com. 

Important Notice About Investing in Regulation CF Offerings:

Investments on the Equifund website are only suitable for investors who are familiar with and willing to accept the high risk associated with Regulation CF Offerings. Securities sold through these types of offerings are not publicly traded and are intended for investors who do not have a need for a liquid investment. Companies seeking capital through Regulation CF tend to be in earlier stages of development and have not yet been fully tested in the public marketplace. Investing in Regulation CF offerings requires high risk tolerance, low liquidity concerns, and long-term commitments. Investors must be able to afford to lose their entire investment. 

You should read the Form C offering statement appearing on the Equifund offering page. It provides more information about the company; the terms of the securities being offered and the risks and other considerations relating to a purchase of these securities. 

Media Contact: 

Jordan Gillissie 

800-777-4003 

336766@email4pr.com 

Alan Condon - Updated Friday, February 25th, 2022 

Despite the COVID-19 pandemic's effect on the spine industry, innovation and mergers and acquisitions activity continues to pick up steam among medtech companies in 2022.  Robotics, navigation, augmented reality, 3D printing and artificial intelligence-based technologies are expected to continue to make noise in the spine industry.  Twenty-three spine companies to watch in 2022:  

15) Kleiner Device Labs (Incline Village, Nev.): Founded by spine surgeon Jeff Kleiner, MD, this startup has acquired 23 U.S. patents for its spine technologies. The company's initial product KG1, demonstrated an ability to increase spinal fusion success rates from 75 to 92 percent. The KG2, or Solid State Fusion Platform, received FDA clearance in September and is designed to provide up to three times the amount of bone-grafting material compared with traditional spinal surgery approaches.

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

Paula Tudoran - January 27, 2022 1:28pm

Kleiner Device Labs is a medical innovation company with a suite of surgical devices protected by 23 patents. The company launched a public offering in the fall of 2021 and while there is limited availability left in the offering, management expects it to oversubscribe shortly. The offering is hosted on a popular private equity platform Equifund, which allows investors of all types to buy shares in early-stage and pre-IPO companies.  

The Company 

Kleiner Device Labs was founded by Dr. Jeff Kleiner, a prominent spinal surgeon with over 25 years of experience and the mastermind behind the company’s innovative KG technology.  According to management, its breakthrough “KG System” has the potential to revolutionize the $14 billion spinal fusion market. The patented technology significantly enhances the first-time success rate of spinal surgeries while lowering operating costs and speeding up recovery times.

Kleiner Device Labs' initial product, KG1, successfully increased spinal fusion success rates from 75% to 92%. The KG1 has received U.S. Food and Drug Administration (FDA) Class II clearance and is now commercially accessible and sold in the United States and the United Kingdom.  The company’s latest technology, the KG2, or Solid State Fusion Platform, is an advancement on the KG1 system and delivers up to three times the amount of bone-grafting material compared to traditional spinal surgery approaches. KG2 received 510K clearance by the FDA this past fall and hopes to obtain a CE mark, which will allow them to sell the KG2 in the European Union.  The Kleiner Device Labs KG System and customized devices like the KG2 aim to accomplish a lot more than merely improving bone graft distribution.  Besides having the potential of increasing surgeries' success rate, the technology can also make surgeries faster, cheaper, easier and safer. It also reduces the risk of trauma to surrounding tissues and improves recovery times.  Management believes its technology has the potential to become the industry standard for more than 350,000 spinal fusion surgeries in the United States each year.

Investment Highlights

Kleiner Device Labs has managed to significantly enhance the first-time success rate of spinal surgeries while lowering operating costs and speeding up recovery times.  The ground-breaking technology is currently protected by 23 U.S. patents (with five more U.S. patents currently pending).  The company was recently granted FDA clearance for its next-generation KG2 device and plans to ramp-up commercial use shortly.  Based on comparable acquisitions in the spine space over the past several years, the company has the potential to generate a return of three to six times the initial investment in the next two to five years if it’s acquired by one of its target medical supply companies.  Due to high investor demand, there is limited space left in the company’s initial public offering.  How to Invest: The offering is available to non-accredited and accredited investors through Regulation CF on the Equifund crowdfunding portal.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Alan Condon - Friday, January 28th, 2022 

Kleiner Device Labs, a startup founded by Jeff Kleiner, MD, has acquired 23 U.S. patents for its spine technologies and plans to break into the spinal fusion market, currently valued at $14 billion, according to Benzinga.  

Dr. Kleiner, a Denver-based spine surgeon with more than 25 years of experience, founded the company in 2013.  "Frustration with existing tools and instrumentation systems led me to develop a suite of tools and techniques which allow open and minimally invasive spinal surgery to be safer, easier and more efficacious," the surgeon said, according to the company's website.  

Kleiner's initial product, KG1, demonstrated an ability to increase spinal fusion success rates from 75 percent to 92 percent and is commercially available in the U.S. and U.K., according to the report.  The KG2, or Solid State Fusion Platform, received FDA 510(k) clearance in September and is designed to provide up to three times the amount of bone-grafting material compared with traditional spinal surgery approaches. 

"Getting adequate graft fill volume and distribution of graft within the intervertebral disc space is one of the most vexing challenges in spinal fusion procedures, which led us to develop the unique flow-thru technology in our KG series products," Dr. Kleiner said.  

Based on comparable acquisitions in the spine industry in recent years, Kleiner Device Labs projects it could generate a return of three to six times the initial investment in the next two to five years if it is acquired by one of its target medical supply companies, according to Benzinga.  

In fall 2021, Kleiner launched a public offering, which the company expects to oversubscribe shortly.

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

WALTER EISNER • THU, OCTOBER 7TH, 2021

The FDA has 510(k) cleared Kleiner Device Labs' KG2 Surge flow-thru interbody system.  Addressing “Vexing” Challenge  In a September 22, 2021, press release, company founder and CEO Jeff Kleiner, M.D., said getting adequate graft and fill volume and distribution of graft within the intervertebral disc space, "is one of the most vexing challenges in spinal fusion procedures."  The company said the system "maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning and grafting process for TLIF and PLIF spinal fusion procedures."  According to the FDA clearance documents, the KG2 is a cage intended for "lumbar intervertebral fusion (PLIF/TLIF approach). The design contains both solid and porous structures formed as a diamond mesh, and it contains a bone grafting hole."  The device is 3-D printed titanium and features a diamond lattice porous structure to facilitate bone ingrowth and may be used with cover plate.  The sterile implant comes pre-assembled on the inserter and includes pre-packaged sterile, single-use instrumentation for primary insertion, graft passing, and cover plate insertion. A reusable set of instruments is included for disc preparation, trial sizing, and repositioning/removal.  “The surgeon opens our tray with a ready-to-use system in their hands. The learning curve is low for operating room staff, and the KG2 Surge system works in both MIS [minimally invasive spine] and open approaches. The associated reusable instrument package allows for immediate revision at every step, should the surgeon desire implant repositioning or removal,” stated the company press release.  The devices will initially be available in footprints of 9x24mm, 11x28mm and 11x32mm, with heights of 7 to 14mm, and lordosis of 0 and 6 degrees.  Indications  According to the FDA documents, the implant is indicated for "transforaminal and posterior interbody fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels.  "The KG2 implant is used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The interbody fusion devices are intended to be used with FDA-cleared supplemental fixation designed for the implanted level."  It took the FDA about four months to clear the device after determining the KG2 is substantially equivalent to predicates from Osseus Fusion Systems, Stryker Corporation (K2M) and NuVasive, Inc.  Here's a short video of how the system works.    

PR Newswire • 09.27.21 

At this week's NASS Annual Meeting in Boston, Kleiner Device Labs will be showcasing the new KG2 Surge flow-thru interbody system that recently received U.S. Food and Drug Administration (FDA) 510(k) market clearance. The company will have the KG2 Surge system for surgeons to handle and test with simulated graft material, and will share the experiences of surgeons who tested the device in cadaver labs.   The new KG2 Surge flow-thru interbody system maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning and grafting process for TLIF and PLIF spinal fusion procedures.  The implant comes preassembled to the inserter in a single-patient-use tray.   "This will be the first conference for surgeons and allograft suppliers to test production-grade samples of this exciting new system for TLIF and PLIF spinal fusion procedures," said Jeff Kleiner, M.D., founder and CEO of Kleiner Device Labs.    NASS attendees can find the company at booth 2345 on the main aisle of the exhibition floor. "Look for the big yellow flow-thru road sign at the corner of our booth," added Mike Hughes, the company's chief commercial officer.   NASS, the North American Spine Society's annual conference, begins Sept. 29 in the Boston Convention and Exhibition Center and runs through Oct. 2.   The company will next launch the product with a select group of surgeons and will be building inventory for its full commercial launch.   A short video demonstrating how the KG2 Surge flow-thru interbody system works is available here.   Kleiner Device Labs is creating new instruments and devices to advance minimally invasive spine surgery and improve outcomes and costs for patients, surgeons, hospitals and payers. Kleiner Device Labs is headquartered in Incline Village, Nev.