DirectSync Surgical

What DirectSync Surgical does

DirectSync Surgical (formerly Evoke Medical, LLC) is a privately held, pre-revenue medical device company headquartered in Lawrence, Kansas, that develops patient-powered smart implants for spine and orthopedic applications. The company's proprietary platform technology converts the mechanical biofeedback of a patient's gait into small, synchronized pulses of DC electrical stimulation at the bone–implant interface — mimicking the body's natural piezoelectric response during activities such as heel strike and toe-off — to enhance bone healing without batteries or external stimulators. The pipeline includes a smart interbody fusion cage for lumbar spinal fusion, a sensor-implant variant that adds diagnostic load-sensing capabilities, and a stated broader roadmap across load-bearing orthopedic sites (femur, tibia, etc.). The differentiated mechanism hypothetically activates both BMP-2 and Wnt pathways for bone growth, and animal studies (10-sheep, 4-month randomized comparative study) demonstrated preclinical safety with no exuberant bone growth.

The business model is hardware sales of Class III implantable devices into the spinal fusion and broader orthopedic surgical market. Target end-customers are spine and orthopedic surgeons and the patients they treat (degenerative disc disease, failed fusions, bone-healing enhancement needs), reached through traditional medical device distribution channels — direct hospital sales forces and medical device GPOs/distributor partners post-approval. Pricing is not publicly disclosed and devices remain investigational pending FDA review. Commercialization has not begun; the company has no reported revenue and is actively raising a seed round to advance the platform toward first-in-human studies and FDA submission.

The company has accumulated $1.75M of non-dilutive NIH SBIR funding across multiple phases (Phase II in 2018, third grant — a Phase I through NIAMS — in 2022), secured issued foundational IP with additional IP pending, completed an FDA pre-submission meeting, and received FDA Breakthrough Device Designation in May 2023. It is led by a co-founder team of a COO (Leighton LaPierre), CTO (Lisa Friis, Ph.D.), and CMO (Paul Arnold, MD) — the latter providing embedded clinical expertise — alongside a commercially experienced CEO (Zygmunt Porada, MBA; over 20 years of medtech experience including Class III product approvals) hired in mid-2022 to drive funding and product strategy. The company operates out of the KU Innovation Park accelerator with 1-10 employees.

Name

DirectSync Surgical

Legal name

Evoke Medical, LLC

Website

https://directsyncsurg.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Ownership category

akta.pro rank

Product category

Orthopedic Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Spine Implants & Motion Preservation (Fusion/Disc/Interspinous) (HLAHAEAC)

akta.pro secondary industries

Orthopedic Joint Reconstruction Implants (Hip/Knee/Shoulder/Elbow/Ankle) (HLAHAEAA), Neurosurgical Implants & Cranial/CMF (Cranial Plates, Dural Repair, Shunts) (HLAHAEAD)

Keywords

• Smart orthopedic implants
• Spinal fusion devices
• Bone healing stimulation
• Biomaterial medical devices
• Human-powered implants

Headquarters

HQ city

Lawrence

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Smart Implant Medical Devices: Pre-revenue company developing implantable medical devices for spine and orthopedic applications. Revenue model will likely be one-time hardware sales through medical device distribution channels targeting healthcare providers.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

DirectSync Surgical develops patient-powered smart implants for spine and orthopedic applications. The proprietary technology uses the body's mechanical biofeedback system to deliver DC electrical stimulation synced with patient motion (walking) at the implant site, eliminating the need for batteries or external stimulators. Products include interbody fusion cages and implants with embedded biomechanically powered sensors for bone healing enhancement and post-operative data collection.

Product overview

DirectSync Surgical offers a platform of patient-powered smart implants designed for spine and orthopedic applications. The core technology includes smart interbody fusion cages and spinal implants that harness the human body's mechanical biofeedback system to deliver electrically stimulation for enhanced bone healing without batteries or external stimulators. The platform includes the primary Smart Implant product with mechanically synced DC electrical stimulation capabilities and an enhanced version incorporating biomechanically powered sensors for post-operative fusion monitoring. All devices are investigational and have received FDA Breakthrough Device Designation.

Differentiator

Problem solved

Functional benefit

Products and services

• Patient-Powered Smart Implant Human-powered implantable device that provides mechanically synced electrical stimulation for enhanced bone healing and post-operative data collection to inform treatment optimization between physicians and patients; no batteries or external stimulators required. Designed for spine and orthopedic surgeons treating degenerative disc disease, spinal fusion, and other orthopedic conditions requiring bone growth.
• Electrically Stimulating Fusion Cage Smart interbody fusion cage that delivers mechanically synced DC electrical stimulation synchronized with patient walking (heel strike and toe off) for the treatment of degenerative disc disease and spinal fusion procedures. Designed for spine surgeons and orthopedic specialists.
• Spinal Fusion Implant with Embedded Biomechanically Powered Sensor Enhanced spinal fusion implant incorporating a biomechanically powered sensor alongside the stimulation-only interbody fusion device, designed to provide diagnostic functionality, fusion process information, and improved long-term outcomes for lumbar spinal fusion procedures. Targeted at spine surgeons seeking post-operative implant data.

Quantifiable outcome

• Animal study demonstrated safety with no exuberant bone growth noted; miniaturized TLIF form factor showed effect

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core and supporting.

• KU Innovation ParkcoreStrategic or Co-development Partner · 1 December 2022DirectSync Surgical established office and lab space at KU Innovation Park Accelerator Suite, providing state-of-the-art workspace, shared technical resources, and integration into innovative ecosystem adjacent to University of Kansas. The Park offers conference rooms, open workspaces, business support services, and access to student business analyst support.
• University CollaboratorssupportingStrategic or Co-development PartnerUniversity collaborators work with DirectSync Surgical to complete grant-funded research and development activities.

Scale indicators4 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Spinal Elements: Spinal Elements is a privately held spine implant company focused on motion-preserving and fusion technologies. Comparable as a direct peer in the mid-size spine implant space, both competing for surgeon mindshare and distribution relationships.
• NuVasive (now part of Globus Medical): NuVasive pioneered TLIF and other minimally invasive interbody approaches before merging with Globus Medical. Their TLIF cage portfolio is the most direct competition to DirectSync Surgical's lead product targeting lumbar degenerative disc disease.
• Orthofix Medical: Orthofix develops spinal and orthopedic stimulation devices, including external bone growth stimulators used in cervical and lumbar fusion. DirectSync Surgical's implantable, battery-free stimulator targets the same fusion healing use case from a more integrated architecture.
• Globus Medical: Globus Medical (post-NuVasive merger) is one of the largest spine implant manufacturers, offering interbody fusion cages and enabling technologies. DirectSync Surgical's smart interbody cage would compete directly with their core lumbar fusion products.

Broad incumbents

• Stryker: Stryker operates a significant spine and orthopedics division (including acquired Wright Medical and Mako robotics) and competes across most implant categories. It is comparable as a broad incumbent that DirectSync Surgical would court as either partner, acquirer, or competitor.
• Zimmer Biomet: Zimmer Biomet is a major orthopedic implant manufacturer with spine and dental franchises. Comparable as a broad incumbent that could serve as a strategic acquirer given DirectSync Surgical's adjacent orthopedic implant applications in femur and tibia.
• Medtronic: Medtronic is a global medical device leader with a major spine and biologics franchise and stimulates-based bone healing products. It is comparable as the dominant incumbent in the spinal fusion space that DirectSync Surgical would either partner with or compete against.
• Boston Scientific (Neuromodulation): Boston Scientific's neuromodulation division develops implantable electrical stimulation devices for spinal and other applications. Comparable as an incumbent in implantable electrical stimulation that could view DirectSync Surgical's stimulation IP as a complementary technology.

Emerging players

• Curiteva: Curiteva is an emerging spine implant company with 3D-printed interbody fusion cages. Comparable as an early-stage spine company commercializing innovative cage technology competing in the same TLIF/lumbar fusion segment.
• Bone Biologics: Bone Biologics is developing biologic-based bone healing solutions targeting spinal fusion. Comparable as an emerging company focused on enhanced bone healing in spine, addressing a similar patient population as DirectSync Surgical's smart cage.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/evokemedical
• LinkedInlinkedin.com/company/evoke-medical

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about DirectSync Surgical