STARTUP: Actuate Therapeutics

Actuate is developing new therapeutic compounds for combination use in high impact carcinomas including glioblastoma, ovarian, breast, and pancreatic cancers. In addition, they are advancing their compounds for the treatment of inflammation leading to fibrosis and neurodegeneration.



INDICATIONS: ADVANCED CANCERS and INFLAMMATION

NEWS:

• Phase 1/2 trial across multiple histologies is currently enrolling patients in leading US and EU institutions (1901 and 1902 Clinical Studies)
• Received FDA Fast Track Designation for 9-ING-41 for treating patients with pancreatic cancer. Aug 2021 Press Release

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STARTUP: Cavalon Therapeutics

FACULTY FOUNDER: D. James Surmeier

Cavalon is focused on mechanisms underlying Parkinson's disease and the targeting of a key neuronal calcium channel involved in the pathophysiology of neurodegenerative and neuropsychiatric disorders.



INDICATION: NEURODEGENERATIVE DISEASES

NEWS:

• Published two manuscripts in 2021 supporting key clinical insights underlying its drug development strategy
• Recently awarded grant funding from the Michael J. Fox Foundation for Parkinson’s Research
• Established an intranasal device partnership to support the Nose-to-Brain delivery of its drug development program



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**FUNDRAISING: Cavalon is currently raising additional foundation and government grant funding to support its preclinical-stage programs, and will be raising seed-stage financing in 2022.

STARTUP: COUR Pharmaceuticals

FACULTY FOUNDER: Stephen Miller

COUR Pharma is developing first-in-class therapies that reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease. COUR's lead product for celiac disease, partnered with Takeda, is the first demonstration of induction of antigen-specific immune tolerance in any autoimmune disease.

INDICATIONS: AUTOIMMUNE DISEASES, FOOD & ENVIIRONMENTAL ALLERGIES, AND RARE DISEASES

NEWS: 

• FDA approval of IND application for clinical study of safety and efficacy of CNP-104 for Primary Biliary Cholangitis. (PBC) Oct 2021 Press Release
• Ironwood Pharma signed an option to acquire exclusive license to develop and commercialize CNP-104, a Treatment of PBC. Nov 2021 Press Release

INDICATION: PEANUT ALLERGY

NEWS:

• FDA approval of IND application for clinical studies of CNP-201 for peanut allergy. Sept 2021 Press Release
• Dosed 1st patient in Phase 1b/2a for CNP-201 for treatment of peanut allergy. Oct 2021 Press Release

STARTUP: Design Pharmaceuticals

FACULTY FOUNDER: Michael Jewett

Design Pharma enables enable rapid discovery and biosynthetic production of drug candidates at unprecedented scale. Their drug discovery engine unlocks the potential of nature-derived small molecule drug discovery by overcoming the many inherent challenges to data mining, access to molecular structures through biosynthesis and engineering inspired rapid design, build and test cycles for hit candidate identification and optimization of lead candidates. Their platform also offers unique opportunities for live biotherapeutics (LBP) and biologics discovery.



APPLICATION: DRUG DISCOVERY



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**FUNDRAISING: Design is currently starting a series A fund raise.



**PARTNERING: Design is interested in continuing to expand its portfolio of pharma collaborations developing shared assets and advancing an internal pipeline of drug candidates for out-licensing. Our platform offers unique opportunities for live biotherapeutics and biologics discovery.

COMPANY: Exicure

FACULTY FOUNDER: Chad Mirkin

Exicure is a clinical stage biotechnology company developing a new class of immunomodulatory and gene regulating drugs against validated targets. Exicure's proprietary spherical nucleic acid (SNA™) architecture is designed to unlock the potential of therapeutic oligonucleotides in a wide range of cells and tissues. Exicure's lead programs address inflammatory diseases, genetic disorders and oncology.



INDICATIONS: GENETIC DISEASES & ONCOLOGY

NEWS:

• Granted Orphan Drug Designation by FDA for Cavrotolimod (AST-008) for the treatment of patients with Merkel cell carcinoma (MCC) and in combination with anti-PD-1/PD-L1 antibodies for patients with advanced or metastatic MCC and cutaneous squamous cell carcinoma. March Press Release
• Achieved response rate threshold to advance patient enrollment in the ongoing Phase 1b/2 Clinical trial of Cavrotolimod. More Details

STARTUP: Inomagen Therapeutics

FACULTY FOUNDER: Rishi Arora

Inomagen is developing gene therapy treatments for patients with chronic atrial fibrillation (AF). The company has identified fundamental molecular mechanisms in the creation of the AF disease state and major trans-genes to selectively target these mechanisms. In proof-of-concept studies, Inomagen’s gene therapy technology has demonstrated a marked decrease in AF in clinically relevant, large animal models (prevention and reversal).

INDICATION: ATRIAL FIBRILLATION

NEWS:

• Awarded $462,689 by NHLBI, with eligibility to receive an additional $3,212,600. April 2021 News Release
• Changed name from Rhythm Therapeutics to Inomagen Dec 2021 Press Release

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**FUNDRAISING: Inomagen is closing a $500k round in the 1Q of 2022.

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STARTUP: Temprian Therapeutics

FACULTY FOUNDER: I. Caroline Le Poole

Temprian is developing a new therapeutic for vitiligo using DNA coding a modified heat shock protein HSP70i to stop the autoimmune responses which can erroneously attack pigment cells.

INDICATION: VITILIGO

NEWS: Received $1M investment by 2Flo Ventures to execute pre-clinical studies with plans to file IND in 2022.

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**FUNDRAISING: Temprian is pursuing a Series A round to support clinical trials.

STARTUP: Terra Bioworks

FACULTY FOUNDER: Neil Kelleher

Terra Bioworks uses synthetic biology tools and technology to clone large microbial DNA pathways encoding rare and valuable small molecule therapeutic “drugs” and reprogram multiple type hosts, such as fungi, bacillus, and streptomyces, to manufacture new and existing natural product drugs. The company has previously cloned and expressed over 110 pathways from bacterial and fungal genomes and >300 pathways from metagenomic soil samples.

APPLICATION: DRUG DISCOVERY

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FUNDRAISING: Terra Bioworks is seeking a $10M Series A.

STARTUP: Vanqua Bio

FACULTY FOUNDER: Dimitri Krainc

Vanqua's lead program is focused on developing small-molecule activators of glucocerebrosidase (GCase), an enzyme that regulates lipid homeostasis in cells, targeting neurodegeneration for Parkinson’s disease and Gaucher disease. In addition Vanqua Bio will also advance programs targeting the innate immune system, which, when overactivated, can accelerate the progression of several neurological diseases.



INDICATION: NEURODEGENERATIVE DISEASES

NEWS: Launched with Series B $85M Financing. Sept 2021 Press Release

STARTUP: Yobee Care

FACULTY FOUNDER: Ruchi Gupta

Yobee has formulated a nature-based, triple-powered scalp, hair, & skin probiotic technology (Probyome™) that quickly and effectively reduces skin inflammation, redness, and itching, and clears the scalp of plaques and flakes.



INDICATION: DRY SCALP AND SKIN

NEWS:

• Ongoing FDA IND Phase I & II clinical trial on the safety and efficacy for dry scalp conditions.
• Overall Therapeutics Winner in Equalize 2021, a mentor program and pitch competition designed to decrease disparity of women academic inventors in entrepreneurship. Oct 2021 Pitch Video

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**FUNDRAISING: Yobee is currently raising a $1M seed round.

Calidi Biotherapeutics, a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, exclusively licensed rights for Prof. Maciej Lesniak's stem cell based products loaded with adenovirus. His work, published in the June 29, 2021 Lancet Oncology, demonstrates safety and efficacy of NeuroNova in patients with newly diagnosed high-grade glioma.  Nov 2021 Press Release

Several Northwestern startups will be in San Francisco from Jan 9-11.

If you would like to meet any Northwestern startups (complete list here) in person or virtually OR hear about new Northwestern incubator programs, please contact us.

STARTUP: Acuitive Technologies

(Sublicensee of NU Startup VesselTek)

FACULTY FOUNDER: Guillermo Ameer

Accuitive has developed a bioresorbable biomaterial technology, known as Citregen™ with unique chemical and mechanical properties for musculoskeletal surgical applications. 



APPLICATION: MUSCULOSKELETAL SURGERY

NEWS: 

• Stryker announced launch of CITRELOCK™ Tendon Fixation Device System. Sept 2021 Announcement
• Received 3 510(k) clearances from FDA for the CITREFIX™ Knotless Suture Anchor System, CITRESPLINE™ and CITRELOCK™ Ligament Reconstruction Devices, and CITRELOCK™ Interference Screw System.  Press Releases

STARTUP: Aivo

FACULTY FOUNDER: Vania Apkarian

Aivo has developed a remote assisted self-care solution for chronic pain patients using proprietary digital biomarkers and machine learning models to create dynamic individualized treatment plans.  individualized treatment plans. Instead of transient pain relief, the Aivo treatment targets the root cause of chronic pain and provides long term pain relief without the risks, costs or side effects of opioids or surgery.



APPLICATION: CHRONIC PAIN

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**FUNDRAISING: Aivo is planning to raise a Series A round ($10-20M) in 2022.

STARTUP: Amphix Bio

FACULTY: Samuel Stupp

Amphix Bio's core technology, the peptide amphiphile nanofiber, uses natural building blocks to instruct cells to initiate regenerative processes. The modularity in the chemistry of the nanofibers enables a wide range of promising therapies for bone, cartilage, muscle, heart and neural regeneration in the brain and spinal cord.

APPLICATION: REGENERATIVE BIOMATERIALS

NEWS:

• Completed $3.8M Fundraising round
• Developed new product formulation for spinal fusion procedures to treat back pain
• Initiated FDA discussion on regulatory pathway for spinal fusion product

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**PARTNERING: Amphix is interested in discussions with potential future investors in the regenerative medicine space.

STARTUP: Dimension Inx

FACULTY FOUNDER: Ramille Shah

Dimension Inx develops 3D-printed therapeutic products, leveraging its next-gen biomaterials platform to create microenvironments that direct the body's cells to rebuild healthy tissues. The company recently submitted a 510K package for its first therapeutic implants for maxillofacial bone reconstruction. It continues to advance its internal pipeline in hard and soft tissue as well as reproductive health, while building revenue-generating strategic partnerships.



APPLICATION: BIOMATERIALS

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**FUNDRAISING: Dimension Inx is planning a Series A round in mid-2022 to advance their internal pipeline and expand commercial infrastructure, building on their $5.7M seed financing.

**PARTNERING: Dimension Inx is interested in join development partnerships for hard and soft tissue regenerative products.

STARTUP: Epicore Biosystems

FACULTY FOUNDER: John Rogers

Epicore produces skin-like wearable microfluidic solution that non-invasively measure sweat biomarkers, skin health, and physiology, in real-time. Epicore is collaborating with strategic partners such as Gatorade, Chevron and LEO Pharma.

APPLICATION: BIOELECTRONICS

NEWS: 

• Received FDA class I designation for the Discovery Patch Sweat Collection System
• Launched 2 products: Gx Sweat Patch and Discovery Patch Sweat Collection System



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**FUNDRAISING: Epicore is in the final stages of completing its Series A investment round ($10M). They have 2 key strategics and several traditional VC investors for this oversubscribed round.



**PARTNERING: Epicore is actively pursuing key strategics in the pharmaceuticals and medical tech sectors to join its Series A.

STARTUP: Lung Healing Technologies

FACULTY FOUNDER: Ankit Bharat

Lung Healing is developing monitors for sensing CO2, O2, and pressure in chest drains.



APPLICATION: CHEST DRAINAGE

NEWS: Completed the Health Wildcatters accelerator program.

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**FUNDRAISING: Lung Healing Technologies is raising $300k in seed funding.

STARTUP: MSI

FACULTY: Gregory Dumanian

MSI has developed Duramesh™, the world's first suturable mesh. Duramesh™ combines the desirable principles of a mesh repair, with the placement precision of a suture. It distributes forces at the suture-tissue interface, while dramatically minimizing the amount of implanted foreign material and surgical complexity required for implantation. Duramesh™ is pending 510(k) clearance and is not yet available for sale in the USA.

APPLICATION: SURGERY

NEWS:

• Received ISO 13485:2016 Certification of its Quality Management System
• Received CE Mark Product Certification allowing market access to the European continent. Duramesh™ is now available for sale in the EU and UK.
• Achieved first clinical use in the EU

STARTUP: Minute Molecular Diagnostics

FACULTY FOUNDER: David Kelso

Minute Molecular Diagnostics has developed a quantitative PCR system that identifies infectious viral and bacterial agents in less than 15 minutes, operated by non-laboratory personnel with less than 1 minute hands on time. DASH's small foot print (11"Dx15"Hx4"W) supports hospital and outside hospital testing.

INDICATION: POC DIAGNOSTICS

NEWS: Awarded $21.3 M from NIH RADx Initiative to accelerate manufacturing of DASH 15 min PCR COVID-19 Test. April 2021 Press Release

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STARTUP: Rhaeos

FACULTY FOUNDER: John Rogers

Rhaeos is developing FlowSense™, a platform technology and noninvasive wireless, wearable skin patch that can monitor bodily fluid flow peripherally throughout the body. The company's first market will be neurosurgery for hospital and home applications.

APPLICATION: CHRONIC MEDICAL CONDITIONS, HYDROCEPHALUS

NEWS:

• Received FDA Breakthrough Device Designation for their first device FlowSense™ scheduled for market launch in 2022. June 2021 Press Release
• Received $4M NIH SBIR grant for outcomes based studies of FlowSense™ Sept 2021 Press Release
• Closed an oversubscribed $2M seed round with value inflection points including FDA de novo 510(k) approval and market launch

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**FINANCING: Rhaeos is closing their seed round this month and looks to connect with potential Series A medical device investors.

**PARTNERING: Rhaeos is interested in opportunities with strategic players in neurosurgery, hydrocephalus and patient monitoring devices.

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STARTUP: Sibel Health

FACULTY FOUNDER: John Rogers

Sibel has developed the ANNE One—a flexible, wireless vital signs monitoring platform for clinical decision-making. Sibel delivers better patient health data through the development of their soft flexible sensors that are powered and operated by advanced software and analytics and cloud-optimized for AI and ML.



APPLICATION: PATIENT MONITORING

NEWS:

• Announced 510(k) clearance from FDA for its ANNE One platform. Oct 2021 Press Release
• Launched ANNE Discovery enabling powerful physiological data collection system for clinical trials with 6 Fortune 500 pharma companies.

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**FUNDRAISING: Sibel is currently raising a Series B round ($40-50M) with participation of Series A investors.



**PARTNERING: Sibel is also interested in joint development opportunities.

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STARTUP: SIA Health

FACULTY FOUNDER: John Kim

SIA has developed DuraSorb®, a fully resorbable synthetic mesh for soft tissue support in reconstructive and cosmetic surgery.



APPLICATION: SURGERY

NEWS:

• DuraSorb is FDA cleared, CE Marked, and commercially available.
• Recently closed oversubscribed $15M Series B to expand direct sales team, with presently over 140 accounts and more than 40 hospitals ordering.

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**PARTNERING: SIA welcomes discussions with key medtech strategics in soft tissue support, general surgery, plastic and reconstructive surgery, and biomaterials.

STARTUP: SwiftScale Biologics

FACULTY FOUNDER: Michael Jewett

SwiftScale Biologics develops cell-free protein synthesis (CFPS) technology, eliminating the constraints of working with living cells in the drug manufacturing process. CFPS leads to faster production times, less variability across batches, and greater scalability with more challenging proteins.

APPLICATION: PROTEIN MANUFACTURING

NEWS: Acquired by National Resilience. Dec 2021 Press Release