Spinal Simplicity announced FDA clearance of a new IFU for its Minuteman family of implants. see more
Spinal Simplicity, a medical device company, today announced the much-anticipated FDA clearance of a new Indication for Use (IFU) for its Minuteman family of implants, Lumbar Spinal Stenosis. Spinal Stenosis is a narrowing of the spinal canal which can lead to back and leg pain, and tingling, numbness, pain, and weakness in the legs and feet. The addition of Lumbar Spinal Stenosis to the existing FDA cleared indications of degenerative disc disease, spondylolisthesis, trauma and tumor allows Spinal Simplicity to identify and treat a new patient population using the Minuteman device.
Spinal Simplicity’s focus is on the design, development and production of orthopedic implants and instrumentation that will change the way physicians treat their patients, improve outcomes and have reproducible results. With a focus on quality, our products are designed to enhance patient care while providing physicians with a greater array of minimally invasive devices. Our innovative technology and sophisticated intellectual property portfolio are forging new territory in the spinal and orthopedic markets.
“Our team could not be more thrilled with today’s news that Spinal Simplicity has been able to add Lumbar Spinal Stenosis as an FDA cleared indication for our Minuteman therapy,” said Todd Moseley, CEO of Spinal Simplicity. “With this announcement, we can enable our prescribers to identify and treat patients who we believe can greatly benefit from the Minuteman implant, patients we previously were unable to help. Patient First is one of our core values and with this new FDA cleared indication, we are now able to help more patients get back to leading a normal life.”
The Minuteman is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- Lumbar spinal stenosis;
- degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- trauma (i.e., fracture or dislocation); and/or
The Minuteman is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (T1-S1).
About Spinal Simplicity
Spinal Simplicity, LLC, headquartered in Overland Park, Kansas, was founded in 2008 with a vision to be the global leader in innovative, simplified surgical solutions, delivering uncompromising quality. The company has successfully been awarded 20+ patents in the U.S. and 65+ patents outside of the U.S., with additional patent applications pending. Spinal Simplicity has regulatory clearance for the Minuteman® system in the US, Europe, and Canada. Our vision is to be the global leader in innovative, simplified surgical solutions while delivering uncompromising quality. For more information, visit spinalsimplicity.com.
Laurent Pharmaceuticals Announces Topline Results from its Phase 2 RESOLUTION Clinical Trial of LAU-7b for the Treatment of COVID-19The double-blind, placebo-controlled trial evaluated the efficacy & safety of once-a-day oral LAU-7b see more
Laurent Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing LAU-7b, a first-in-class pro-resolving drug candidate, reported today topline results from its Phase 2 RESOLUTION clinical trial in hospitalized COVID-19 patients. This double-blind, placebo-controlled trial evaluated the efficacy and safety of once-a-day oral LAU-7b, administered for 14 days on top of standard of care. The trial randomized a total of 232 hospitalized patients with moderate, severe or critical COVID-19 disease, of which 148 patients had moderate-to-severe disease (not requiring oxygen or requiring low-flow oxygenation) and 84 were critically ill COVID-19 patients requiring high-flow oxygen but not mechanical ventilation.
In the overall moderate-to-critical patient population, the study did not meet its primary endpoint of improving the proportion of patients alive and free of respiratory failure on Day 29 (LAU-7b: 81/117 patients, 69.2% versus Placebo: 83/115 patients, 72.2%; p=0.74).
A clinically meaningful efficacy signal was achieved in the pre-specified subgroup moderate-to-severe COVID-19 patients (n=148, representing 64% of the overall study population), with LAU-7b plus standard of care demonstrating a 100% reduction in the risk of all-causes death and the risk of progressing to mechanical ventilation by Day 60, when compared to placebo plus standard of care. More specifically, none of the 76 moderately to severely ill patients treated with LAU-7b plus standard of care died or progressed to mechanical ventilation, while 4 patients died (4/72, 5.6%, p=0.053) and 5 progressed to mechanical ventilation (5/72, 6.9%, p=0.025) in the placebo arm. The study also showed an improvement of 6.9% relative to placebo (p=0.055) in the proportion of patients alive and free of respiratory failure at Day 29 treated with LAU-7b, in this moderate-to-severe COVID-19 patient population.
The results from the moderate-to-severe subgroup are very promising, suggestive of a potential clinical benefit of LAU-7b in COVID-19 patients that are not yet in respiratory failure, which also represents the patient population with the fewest treatment options”, said Radu Pislariu, MD, President and CEO of Laurent Pharmaceuticals. "An oral therapeutic that prevents serious COVID-19 illness and death, also allowing patients to continue the treatment at home after discharge from hospital, would be a powerful tool in the therapeutic arsenal against COVID-19”, added Dr Pislariu.
“Avoiding ventilatory support in this common subset of hospitalized patients is a very desirable goal as it prevents ICU overload and protects the patients from complications that may occur after ventilatory support is initiated”, said Dr Barry Meisenberg, MD, clinical investigator in the RESOLUTION trial. “Subsequent clinical development in a larger moderate-to-severe patient population will allow confirming the positive results observed with LAU-7b” added Dr Meisenberg, who is also the chair of the Department of Medicine of the Anne Arundel Medical Center in Annapolis MD, United States.
LAU-7b was well-tolerated, with a safety profile comparable to the placebo arm and consistent with the existing safety data. The concomitant standard of care was evenly distributed among the treatment arms. The subgroup analysis of critically ill COVID-19 patients didn’t show an improvement in the LAU-7b arm over placebo, suggesting that patients already in respiratory failure at baseline may be too severely affected by the disease to benefit from the LAU-7b treatment.
Based on these results, the company plans to focus its future development on patients with moderate-to-severe COVID-19 disease and on the key endpoints associated with the observed clinical benefit, and will seek guidance from the regulatory agencies on potential strategies moving forward, which may include amending and extending the RESOLUTION trial.
LAU-7b is a novel oral form of fenretinide, an atypical retinoid that acts on certain cell membrane lipids involved in both viral replication and immune-inflammatory responses. LAU-7b was initially developed for its potential to trigger the resolution phase of inflammation, a natural mechanism that keeps the inflammatory response under control, without inducing immune-suppression (a “pro-resolving” effect). More recently, fenretinide was shown to have antiviral activity in vitro against SARS-CoV-2 and synergistic potential when combined with remdesivir, evocative of different mechanism than typical antivirals. LAU-7b is believed to work by decreasing cell membrane fluidity required for virus entry and release, as well as reducing de novo lipid synthesis required for pathogen proliferation.
About Laurent Pharmaceuticals
Laurent Pharmaceuticals is a clinical stage biotech company focusing on the modulation of cell membrane lipids for addressing complex conditions caused by an unbalanced immune-inflammatory response. The company’s lead drug candidate, LAU-7b, is a proprietary oral formulation based on fenretinide, an atypical retinoid with a well-documented safety profile established in more than 3,000 patients. Existing data suggest that low-dose fenretinide has the potential to modulate certain membrane lipids and exerts inflammatory-controlling, antifibrotic and antiviral properties. LAU-7b is currently being evaluated as a potential therapeutic for Cystic Fibrosis and COVID-19. For more information, please visit www.laurentpharma.com.
Salarius announced its inclusion in the FTSE Global Micro Cap Index see more
Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with sarcomas, pediatric cancers, and other hematologic and solid tumors, today announced its inclusion in the FTSE Global Micro Cap Index. Salarius’ inclusion in the FTSE index will be effective after the U.S. market opens today, Monday, September 20, 2021.
“The addition of Salarius to the FTSE Global Micro Cap Index is the latest event in what has been an exceptional year for the company, highlighted by the strengthening of the company’s financial position and significant progress in our clinical programs,” stated David Arthur, Chief Executive Officer of Salarius Pharmaceuticals. “The FTSE Global Equity Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. This listing will help us pursue our goal to drive long-term shareholder value by expanding awareness of our company within the investment community, increase the liquidity of our stock and broaden our shareholder base."
The FTSE Global Micro Cap Index is part of the FTSE Global Equity Index Series (GEIS), which includes 16,000 large-, mid-, small-, and micro-cap securities across 49 developed and emerging markets globally. As of July 30, 2021, The FTSE Global Micro Cap Index had a net market capitalization of $1.89 trillion and included 8,832 constituent companies. Companies domiciled in the U.S. represent 47% of this index, while globally, the healthcare industry constitutes 17.65% of the index.
About FTSE Russell:
FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indices that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes that are used by institutional and retail investors globally. FTSE Russell is wholly owned by the London Stock Exchange Group. For more information, visit www.ftserussell.com.
About Salarius Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options. Salarius’ lead candidate, seclidemstat, is being studied as a potential treatment for pediatric cancers, solid tumors and other cancers with limited treatment options. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma and select additional sarcomas that share a similar biology to Ewing sarcoma, also referred to as Ewing-related or FET-rearranged sarcomas. Seclidemstat has received Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation for Ewing sarcoma from the U.S. Food and Drug Administration. Salarius is also developing seclidemstat for several cancers with high unmet medical need, with a second Phase 1/2 clinical study in hematologic cancers. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program and was also a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit salariuspharma.com or follow Salarius on Twitter and LinkedIn.
ID Genomics has received nearly $300,000 under a Phase I STTR grant from NIH. see more
Diagnostics startup ID Genomics will accelerate its development of a quick test for variants of the COVID-19 virus with a new grant from the U.S. National Institutes of Health.
The Seattle-based company announced the $300,000 small business grant Tuesday for the dipstick-based test, currently dubbed CovNET. ID Genomics is also eligible for a follow-on grant of up to $3 million.
Most tests for the virus simply provide a ‘yes’ or ‘no’ answer to whether someone is infected. ID Genomics’ prototype test can also distinguish which variant an individual is infected with, and it can do so within two hours.
That’s faster than the gold-standard method, which involves sequencing the genome of the virus to detect variants. Some existing rapid tests can also pick up a single variant or a few, but CovNET stands out by distinguishing among dozens, according to ID Genomics’ co-founder Evgeni Sokurenko.
Sokurenko co-founded ID Genomics in 2014 with the goal of combining epidemiological surveillance, bioinformatics and molecular diagnostics. The 6-person company provides a variety of services to identify different microbes and their subtypes.
In addition to developing the CovNET rapid test, ID Genomics will launch a next-day sequencing service for variants within the next few weeks. The researchers showcased their sequencing approach in a recent study of a variant that emerged in California.
But the new two-hour test could ultimately be easier to deploy and potentially cheaper, aiding “real-time” monitoring of current and emerging variants, said Sokurenko, who is also a professor of microbiology at the University of Washington. The UW is the academic partner on the grant.
Sokurenko said that easy detection of variants could “help with close monitoring of pandemic dynamics, viral evolution and spread as well as timely detection and containment of local outbreaks.” In addition, better detection could support the development of treatments tailored to each version of the virus.
New variants are continually emerging, and the highly contagious delta variant is now dominant in the U.S. and many other countries. The World Health Organization has identified three other ‘Variants of Concern.’ These variants are known to be nastier than the original version of the virus, for instance transmitting more easily or making people sicker.
ID Genomics aims for an easy-to-use test that could be rapidly deployed across epidemiological surveillance labs globally. “With all stars aligned, we might start selling the test kit within months,” said Sokurenko of CovNET. “Affordability is the goal,” he added.
The prototype CovNET test uses a technique called PCR to identify variants, which show up as bands on a strip. The location and intensity of the bands can identify the predominant variant in a sample. Each double-sided strip can identify up to 24 variants and using more strips enables detection of more variants.
The company is also developing a smartphone app to rapidly decode the bands and identify which variant they correspond to.
CovNET adapts components of technology built by Bothell, Wash.-based IEH laboratories for other types of tests. IEH Laboratories is also collaborating with ID Genomics to a develop a pocket-size “nanocycler” to incubate the samples. The battery-powered device is capable of the rapid cycles of heating and cooling in the PCR portion of the test, which amplifies the genetic material of the virus.
The new grant will enable the startup to optimize the prototype test and validate it on a large number of clinical samples. ID Genomics is also working on agreements for manufacturing and distribution.
There is a growing pool of diagnostic tests for COVID-19, many tracked by Seattle-based PATH. New tests include a home-based PCR test to detect the virus from Amazon, and a test that can also tell if you’ve been infected with the virus in the past, developed by Seattle-based Adaptive Biotechnologies in partnership with Microsoft.
But there is a need for tests that can enable more efficient surveillance of variants. Washington state is currently sequencing close to 20% of virus samples for variants, but that is more than most states and many national labs.
FEMSelect, Ltd. Announces CMS Reimbursement for Innovative Minimally Invasive Approach to Pelvic Organ Prolapse Repair ProcedureCMS has created a new HCPCS code based on a New Technology APC application submitted by FEMSelect see more
FEMSelect, Ltd., a medical device company addressing unmet needs in the field of pelvic health, announced today that the Centers for Medicare and Medicaid Services (CMS) has created a new HCPCS code (C9778) to describe the procedure associated with the EnPlace® system – vaginal colpopexy by sacrospinous ligament fixation (minimally invasive extra-peritoneal approach), based on its review of a New Technology APC application submitted by FEMSelect. In the final 2022 OPPS Payment Schedule that was released by CMS last week, the EnPlace procedure is positioned for appropriate payment as a Level 5 GYN procedure as well as designated as device-intensive, enabling broader access to EnPlace for women in the ambulatory surgery center (ASC).
Pelvic organ prolapse is a medical condition in which one or more female pelvic floor organs (i.e., bladder, uterus, rectum) shift and descend – creating an extremely uncomfortable condition. Half of women over the age of 50, 25 million women in the U.S. alone, will suffer from a pelvic floor condition in their lifetimes. Prolapse symptoms include discomfort, embarrassment, and urinary and sexual dysfunction, among others that commonly cause loss of productivity, depression, and decreased quality of life.
A vaginal procedure with the EnPlace System, the only minimally-invasive platform indicated for attaching sutures to ligaments of the pelvic floor, involves an outpatient procedure with no use of pelvic floor mesh. "The establishment of CMS reimbursement for EnPlace is a major milestone for FEMSelect and the clinical community," said Debbie Garner, Co-CEO of FEMSelect. "We are excited about the opportunity this presents for millions of women in the U.S. who suffer from the symptoms of pelvic floor prolapse, which greatly impacts quality of life."
HCPCS code C9778 was granted by CMS to describe the specific EnPlace approach, as a Minimally Invasive Extraperitoneal Colpopexy.
Colpopexy, Minimally Invasive, Extraperitoneal
The EnPlace technology is available nationwide through FEMSelect's exclusive partner in the U.S.—LiNA Medical USA.
FEMSelect is a women-led company with a mission to make a lasting impact on women's health by delivering innovative technologies that provide consistent results in a patient-centric manner and dramatically improve outcomes for women. For more information, visit: https://femselect.com.
About LiNA Medical USA
LiNA Medical USA specializes in selling innovative, minimally invasive devices in the fields of gynecology and urology. The company is dedicated to partnering with organizations that offer related products that improve the lives of patients and the healthcare professionals that treat them. For more information, visit: https://linamed.com.
Arovia launched Splay, an expandable display & ultra-short-throw pico projector in 1, on Kickstarter see more
Arovia launched Splay, an expandable display and ultra-short-throw pico projector in one, on Kickstarter. The 24.5-inch FHD portable display expands and folds in seconds and transforms into a projector. Splay is available for the super early bird price of $649 (MSRP: $1299).
Splay quickly shifts from the largest portable display on the market to ultra-short-throw projector mode - all while folding down to the size of a book, weighing just 2.5 pounds. It’s made from patent-granted technology and is the perfect companion on the go for office workers, movie lovers, gamers, photographers and videographers, travelers, medical workers, disaster relief workers, and more.
“We are so excited to launch the world’s largest portable display and the world’s only 2 in 1 display and projector,” said CEO and Co-Founder Alexander Wesley. “We’ve worked extremely hard to bring something unique to the market and to our backers. With our patented technology and multiple functionalities, we think this is something people are going to love.”
In display mode, Splay has a four-hour battery life on a single charge and can also act as a power bank. It has a 24.5” FHD screen size with a bright 800 nits screen with 1920x1080 FHD quality. Splay easily connects to a phone, tablet, or laptop via HDMI or wireless adapter (e.g. Chromecast, Apple TV). The space-saving display and projector also includes loud and powerful speakers for an immersive experience.
In under a minute, users can remove the display technology, press a button to flip the image, and begin projecting on a wall to project an 80” FHD image from less than two feet away. Projector mode provides full HD, with a bright 1920 x 1080 high-resolution display, up to 80” screen size, and a throw ratio of 0.39, making it perfect for use in small spaces. This is the shortest throw ratio (focal length) projection display of any similar portable projector device weighing less than five pounds.
While traditional projector screens are vinyl or plasticizer-based that wrinkle when folded, Splay is the only display that can fold and expand in all directions without permanent wrinkles. While rollable or foldable OLED can only roll or fold in one direction. Splay is the only patented fully flexible, high quality, projector screen on the market.
Splay is a massively upgraded version of SPUD, launched by Arovia in 2016. Splay boasts a higher resolution, significantly increased brightness, is lighter by .5 pounds, has a re-imagined industrial design and is 30% smaller when expanded and folded. Best of all, it has the new projector mode, making it a 2-in-1 device.
“We built Splay from the ground up using the lessons we learned from making SPUD to create the ultimate portable display,” said CTO and Co-founder George Zhu. “We have made game-changing advances on our patented technology and can’t wait for our backers to experience Splay themselves.”
To back Splay and view early bird discounts, visit the Kickstarter page.
Arovia is led by co-founders Alexander Wesley and George Zhu.
Alexander Wesley - CEO and Co-Founder - Alex was recognized by CNBC as the creator of the expandable display industry. He was formerly a product manager at ZYGO corporation, the top optical precision measurement company in the world. He has his B.S. and M.S. in optical engineering from the University of Rochester, the top optics school in the world. He also has an MBA from Rice University, where he was recognized as one of the top 150 U.S. MBAs to graduate in 2016 by Poets and Quants.
George Zhu - CTO and Co-Founder – George developed Arovia’s core intellectual property, including the one-step expand mechanics and the first fully foldable projector screen. He is the primary system architect of SPUD and Splay, leading all technical development. George has his B.S. in Mechanical Engineering from Rice University and was recognized as a top 5 engineer in his graduating class.
Salarius Pharmaceuticals Receives $2.7 Million in Payment from the Cancer Prevention and Research Institute of TexasSalarius today announced the receipt of $2.7 million payment under its existing contract with CPRIT see more
Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with sarcomas, pediatric cancers, and other hematologic and solid tumors, today announced the receipt of a $2.7 million payment under its existing contract with the Cancer Prevention and Research Institute of Texas (CPRIT). The payment is part of a non-dilutive grant that was originally awarded in 2016 to support Salarius’ operations and development of its lead drug candidate, seclidemstat. Seclidemstat (SP-2577) is a novel, oral tablet, reversible inhibitor of lysine-specific histone demethylase 1 (LSD1), an enzyme that plays a key role in the development and progression of several cancers.
This latest disbursement of CPRIT funds is additive to the $33 million in cash Salarius previously reported on its balance sheet as of June 30, 2021, and up to $2.1 million in funding remains available to Salarius under the original 2016 CPRIT Award.
“The non-dilutive financial support Salarius has received from CPRIT during the past five years continues to play an instrumental role in our success in advancing the development of seclidemstat,” stated David Arthur, CEO of Salarius. “Since the original CPRIT grant, Salarius has initiated research partnerships, fortified its intellectual property portfolio and expanded the exploration of seclidemstat into new cancer indications. In all, patients are being actively recruited for clinical trials across five patient groups, three in high unmet need sarcomas and two in high unmet need hematologic cancers.”
Founded in 2007 with a $3 billion bond issue and extended with an additional $3 billion bond issue in 2019, CPRIT funds cancer research and prevention services in Texas. Salarius was awarded a product development research grant in May 2016 for the development of seclidemstat and the disbursements are based upon Salarius’ achievement of specific goals and objectives. Under the grant agreement, Salarius must provide matching funds equal to 50 percent of the CPRIT funding and make a good faith effort to spend at least half of the CPRIT grant and matching monies within the State of Texas with Texas-based employees or contractors.
About Salarius Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options. Salarius’ lead candidate, seclidemstat, is being studied as a potential treatment for pediatric cancers, sarcomas and other cancers with limited treatment options. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing sarcoma and select additional sarcomas that share a similar biology to Ewing sarcoma, also referred to as Ewing-related or FET-rearranged sarcomas. Seclidemstat has received Fast Track Designation, Orphan Drug Designation and Rare Pediatric Disease Designation for Ewing sarcoma from the U.S. Food and Drug Administration. Salarius is also developing seclidemstat for several cancers with high unmet medical need, with a second Phase 1/2 clinical study initiated by the MD Anderson Cancer Center in hematologic cancers. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program and was also a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit salariuspharma.com or follow Salarius on Twitter and LinkedIn.
ActX now has a validated app in the Cerner Open Developer Experience (Code) program. see more
ActX, a leader in personalized and precision medicine, is proud to announce that it now has a validated app in the Cerner Open Developer Experience (Code) program.
The ActX Genomic Profile is a SMART on FHIR app integrated into Cerner Millennium EHR. It provides dynamic and frequently updated genomic reporting and clinical decision support to providers, eliminating the need for PDF’s. ActX is laboratory agnostic, allowing sites to import genetic results from any clinically valid laboratory. Enabling the ActX Genomic Profile app within Cerner Millennium is a small project for the IT team and can be accomplished in a matter of weeks.
ActX provides genomic decision support that facilitates personalized prescribing and actionable risk management based on a patient’s unique genetic profile, all within the provider’s workflow. The clinician can be alerted if a medication is likely to be ineffective, cause side effects, or need a dosing adjustment, based on the patient’s genetics. With one click in the Millennium patient chart, providers will have access to their patients’ genomic profiles, offering insight into drug genomic interactions, hereditary risks, and carrier status. Having an integrated patient genomic profile enables providers to proactively tailor care plans to the individual.
“We are excited to become a Cerner Code validated app, which makes it easier for health systems to integrate the ActX Genomic Service,” said Andrew Ury, M.D., ActX CEO. “ActX helps to improve patient care using a precision medicine approach. We help the patient get the right medication at the right dose the first time, and to receive proactive care to avoid actionable risks, all built into the provider’s workflow within Millennium.”
The $11.9 million in recent investment will help CleanFiber to continue on its growth curve. see more
The company, which makes insulation for buildings at its plant in Blasdell, has attracted an additional $11.9 million in investment, most of it generated by referrals, said Jonathan Strimling, the CEO.
"Just about every investment that's come in either from somebody already in the business or somebody they know, and they tell about it," he said. "The good news is, word is spreading organically about what we do."
To date, CleanFiber has raised $39 million in investment, including $500,000 as a prize winner in the 2016 43North competition. The company, which used to be called UltraCell, relocated here from Massachusetts. The $11.9 million in recent investment from multiple sources will help CleanFiber to continue on its growth curve, Strimling said.
"It's all about scaling up production at our facility, so there's a fair bit of investment we'll make in equipment and people and bringing up additional capacity," he said. The company makes high-performance insulation from recycled corrugated cardboard.
CleanFiber has about 45 employees and doesn't expect that number to go much higher. But the company does have its eye on adding production facilities elsewhere in the country.
"This is a product that's used nationally and internationally, and it's just not practical to supply customers in California from Buffalo," Strimling said.
Aligned Climate Capital invested $4 million in the business, and Western New York Impact Investment Fund invested $500,000 in the latest round.
“CleanFiber produces a clean, cost-effective alternative to foam and fiberglass insulation using materials that are carbon negative,” said Peter Davidson, CEO of Aligned Climate Capital. “We see a tremendous opportunity for growth driven by consumer demand and strong policy incentives at the federal and state level.”
43North provided $300,000 in follow-on funding to CleanFiber and has helped the company navigate state policies and regulations since it moved here, Strimling said.
Some of CleanFiber's other investors have also been helpful beyond their funding commitments, by making introductions, providing business contacts and making referrals to other investors, Strimling said. He said CleanFiber has made inroads with its product, while some of its insulation competitors – which rely on recycled newsprint as feedstock – have struggled with supply issues.
CleanFiber has recorded "substantial growth" in sales this year, but the CEO declined to disclose figures.
The funds raised from notable organizations and angel investors to support school districts see more
Amidst a wave of challenges to deliver high-quality math curriculum in a shifting education environment, Levered Learning announced it has secured $1.5M in a Seed Round. Levered’s individualized elementary instructional system has been proven to increase elementary math proficiency. The funds raised from notable organizations and angel investors will help the company build on its success supporting school districts in their efforts to help every student achieve, and go beyond, proficiency in math.
American Family Insurance Institute for Corporate and Social Impact joined the round. The venture capital fund invests in startups that are building scalable approaches to solve some of this country’s most challenging problems, believing that social innovation can accelerate equity in education and help more students thrive in school.
“When I taught graduate students training to become teachers, year after year one of their biggest concerns was feeling uncomfortable teaching math or being overwhelmed with attending to individual needs. From the moment I met the team at Levered," remarked Dr. Joy Ippolito, Social Impact Investment Director, American Family Insurance Institute for Corporate & Social Impact, "I knew that this was a great math product to help solve those problems. It simplifies the instructional process for teachers, giving them real-time insight into individual performance. More importantly, it demonstrates measurable results for kids who are struggling in math. We are thrilled to be working with the Levered team to help bring this product into more schools.”
Other investors in the round include:
Central Coast Angels, an early stage angel group interested in innovative companies who are building businesses located in the Central Coast region of California. Central Coast members include senior executives who helped build companies such as, Apple, Macromedia, Microsoft, Palm, Paypal, and Symantec. Ed Colligan, former President of Handspring and Palm, Inc. has also joined Levered’s board.
Sandalphon Capital, a midwest-focused venture capital firm investing in scalable, problem-solving businesses with high growth potential.
Keiretsu Forum Northwest, the largest global investment network with over 50 chapters and over 3,000 accredited private equity investors, venture capitalists, family offices and corporate/institutional investors.
Levered will use the funds to support sales growth and expand its curriculum offering. The company’s 2019 Pilot Study Brief conducted by Digital Promise quantified the impact of Levered’s next-level blending learning system:
- 100% of teachers reported that their students developed more confidence in math using Levered.
- 100% of pilot teachers reported that students were excited about learning when using Levered.
- Overall growth in math from 3rd to 4th grade was 170% of the California average growth on the state test. Economically disadvantaged students in the pilot group saw 184% growth of the state average.
“Our learning system is designed to support teachers in reaching every student, every day, while students have the runway and support they need to be successful,” said CEO, Mitch Slater. “That is the most powerful combination to improve student achievement and offer all students a pathway to success in learning math.”
About Levered Learning
Levered Learning, founded in 2017 in Soquel, California, is a 21st century online individualized blended learning math system created by teachers and educators to provide the right level of support and challenge for every student. Levered provides teachers with real-time data on student progress with tools to support intervention and enrichment and provides insights on engagement. The Levered Learning System is proven to increase learning growth by 70% on state testing in the first year of implementation. Levered is the only core math curriculum product to receive both Digital Promise’s Learner Variability and Research-based Design certifications.
Orion announced that it is receiving advisory services and conditional funding from the NRC IRAP see more
Orion Biotechnology Canada Ltd., a clinical stage company unlocking the therapeutic potential of G Protein-Coupled Receptors (GPCRs) with a novel drug modality, proven discovery platform and best-in-class molecules, today announced that it is receiving advisory services and conditional funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP). The funding will support the development of Orion’s lead compound, OB-002, a GPCR analog of CCL5 with best-in-class potency and broad applicability across a range of serious diseases including cancer and neuroinflammation. Working in collaboration with NRC’s Human Health Therapeutics Research Centre, the objectives of the project will be to further expand the translational research of OB-002, including an assessment of the molecules’ ability to cross the blood brain barrier (BBB).
“We are very pleased to receive advisory services and this funding from NRC IRAP,” said Mark Groper, President and CEO of Orion Biotechnology. “Their support will help accelerate development of OB-002 as a potentially important therapy for the treatment of serious illnesses”.
“GPCRs are implicated in a wide range of human physiological processes and we are interested in expanding our knowledge of OB-002’s pharmacological profile and mechanism of action,” commented Ian McGowan, Orion’s Chief Medical Officer. “This project, supported by NRC IRAP and our collaborators, will prove important as we continue to progress OB-002 into the clinic”
About Orion Biotechnology
Orion Biotechnology Canada Ltd, is a clinical stage biotechnology company focused on the discovery and development of precision engineered G-Protein Coupled Receptor (GPCR) targeted therapeutics. Leveraging its proprietary drug discovery platform, Orion is advancing a promising new class of highly potent drugs to unlock a set of high-value GPCR targets that have proven very challenging using traditional drug classes. Orion’s lead candidate, OB-002, is a first-in-class Chemokine Analog and best-in-class CCR5 antagonist. With close ties to diverse institutions and experts around the globe, and a highly innovative proprietary drug discovery platform, Orion is uniquely positioned to stimulate the rapid development of promising new treatments for serious diseases. Learn more at www.orionbiotechnology.com.
HaptX, the leading provider of haptic gloves, today announced a multi--year partnership with Haption see more
HaptX, the leading provider of realistic haptic gloves for VR and robotics, today announced a multi-year, exclusive partnership with Haption, the France-based producer of premium force feedback devices, to accelerate the commercial introduction of full-body haptic devices.
HaptX Gloves are the only haptic wearable with true-contact haptics that physically displace the user’s skin the way a real object would. HaptX Gloves feature more than 130 points of tactile feedback and 40 lbs. of force feedback per hand, as well as a proprietary magnetic motion capture system with the industry’s highest level of precision.
The integration of HaptX’s market-leading haptic wearables and Haption’s best-in-class force feedback devices will enable an unprecedented level of immersion and realism for professionals in training and simulation, industrial design, and robotics. With the announcement of this partnership, Haption will discontinue the production of Haption HGlove haptic gloves and exclusively market HaptX Gloves to their customers.
“HaptX has invested nearly a decade of research and development to design and manufacture haptic devices for the hand and beyond,” said Jake Rubin, founder and CEO of HaptX. “We’re excited to leverage Haption’s commercially proven Virtuose platform to help bring our transformative technology from lab to marketplace.”
“Haption has developed advanced force feedback systems for over 20 years,” said Jérôme Perret, CEO of Haption. “We’re thrilled to combine our best-in-class force feedback with HaptX’s unique true-contact haptics to deliver a new level of fidelity and immersion for our customers’ mission-critical applications.”
HaptX builds technology that simulates touch sensation with unprecedented realism. HaptX Gloves enable natural interaction and true-contact haptics in virtual reality and robotics for the first time. A venture-backed startup, HaptX is headquartered in Redmond, WA, with offices in San Luis Obispo and San Francisco, CA.
Haption designs, manufactures and sells hardware and software solutions based on force feedback. Founded in 2001, the company partners with industry leaders to provide professional level force feedback for medical, robotic, nuclear and industrial applications.
Kineta Presented Compelling Preclinical Data on its New CD27 Antibody Program at the 2021 SITC Annual MeetingKineta has developed a diverse set of anti-CD27 agonist antibodies. see more
Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today the presentation of preclinical data on the company's new anti-CD27 agonist monoclonal antibody program at the Society for Immunotherapy of Cancer (SITC) 36th Anniversary Annual Meeting, that took place November 10-14, 2021 in Washington D.C. Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta, presented a poster revealing new binding affinity and specificity data on the company's CD27 monoclonal antibody drug candidates as well as potent agonistic activity on cellular and T cell activation assays.
"We are highly encouraged with the compelling preclinical data demonstrated with Kineta's new CD27 monoclonal antibodies" said Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta. "CD27 is a promising cancer immunotherapy approach that can mobilize new specific tumor antigen specific T cells to drive a potent anti-tumor response with single agent efficacy as well as synergistic effects with other immune checkpoint inhibitors.
Kineta has developed a diverse set of anti-CD27 agonist antibodies. They are fully human monoclonal antibodies (mAbs) that demonstrate low nanomolar (nM) binding affinity to CD27 in humans. In preclinical studies, Kineta's selected lead anti-CD27 agonist mAbs induce T cell proliferation and secretion of cytokines involved in T cell priming and recruitment, demonstrating the ability to potentiate new anti-tumor responses. Kineta is in the final stage of lead selection and plans to nominate a clinical candidate in Q1-Q2 2022.
Key results from the SITC poster presentation:
- 147 fully human anti-CD27 monoclonal antibodies with unique sequences were generated
- Anti-CD27 agonist assay showed strong agonist activity for 8 pre-selected anti-CD27 antibodies
- Human T cell activation assay data for 5 mAbs showed increased proliferation and cytokine secretion
- Further in vitro and in vivo developments are on-going to select our lead anti-CD27 agonist antibody
Title: A promising cancer immunotherapy target: Novel agonistic human antibodies against the human T-cell costimulatory receptor CD27
Date Presented: November 12-13, 2021
Presenter: Thierry Guillaudeux, PhD
Poster: Click on the link below to view the poster:
Kineta is a clinical stage biotechnology company with a mission to develop next generation immunotherapies that transform patients' lives. We have leveraged our expertise in innate immunity to develop first or best-in-class immunotherapies that address the major challenges with current cancer therapy.
UbiQD rolls out electricity-producing windows see more
Los Alamos-based UbiQD, an advanced materials company, has started installing energy-generating windows on commercial buildings.
The company's headquarters, a hotel and the U.S. Department of Energy's National Renewable Energy Laboratory in Golden, Colorado received the high-tech window treatment, according to a release from UbiQD.
The installations serve as pilots for one of the company's products, two-piece windows made with glass that is laminated with its "quantum dot" technology in the middle. When the "dots" release protons which can be harvested by the windows, outfitted with solar cells, to create electricity.
The window trials aim to test parameters such as window orientation, time of day, seasonality, temperature and manufacturing, the release says. The windows were "made with support" from window manufacturer Glaz-Tech Industries in Albuquerque, the release adds.
UbiQD plans to begin deploying more solar windows next year, with additional projects slated for New Mexico, Colorado and Washington, according to the release. The company was founded in 2014 and also offers windows for greenhouse operations and a special kind of ink that acts as a security measure to combat counterfeit items.
The startup also announced a $7 million investment round in December 2020. The round included $4.5 million in new investment plus a previously-secured convertible note, founder and CEO Hunter McDaniel previously said.
Investors included Scout Ventures, which confirmed that it co-led the round, as well as Santa Fe's Sun Mountain Capital, Plug and Play Ventures and others, according to UbiQD.
HaptX took home the award for Best in Show for the virtual reality category at Augmented World Expo see more
HaptX took home the award for Best in Show for the virtual reality category at Augmented World Expo (AWE), the world’s largest VR/AR expo. The event, held in Santa Clara from November 9-11, marked the public debut of HaptX Gloves DK2, the world’s most advanced haptic feedback gloves.
At an event of more than 200 exhibitors, HaptX was one of the two “Best in Show” winners. HaptX took home the Auggie for the VR category, while Niantic was recognized for the AR category. Chief Revenue Officer Joe Michaels kicked off the first day of AWE with an on-stage presentation, Drop the controller: How realistic touch feedback increases your effectiveness in enterprise VR.
HaptX’s booth saw high demand from XR industry leaders, press, and virtual reality enthusiasts alike. Expo visitors could experience HaptX Gloves DK2 first-hand, feeling true-contact haptics in two different demonstrations.